BI-MONTHLY NEWS LETTER OF BULK DRUG MANUFACTURERS ASSOCIATION (INDIA)

C-25, Industrial Estate, Sanathnagar, Hyderabad - 18, India. Ph : +91 40 23703910, 23706718, 23704804 e-mail : info@bdmai.org, bdma.hyd@gmail.com l Website : www.bdmai.org

OCTOBER-NOVEMBER 2018

National President Shri V.V. KRISHNA REDDY

President-(Emeritus) Shri M. NARAYANA REDDY

Senior Vice-President Shri R.K. AGRAWAL

Vice-President (North Zone) Shri B.R.SIKRI

Vice-President (West Zone) Shri NARESH K. GUPTA

Vice-Presidents (South Zone) Shri S. MANI

General Secretary Shri R. SRINIVASA RAJU

Secretary Shri M. VIJAY KIRAN

Treasurer Shri P. ANUP VEER

SUBSCRIPTION TARIFF

Members : Free OPINIONS EXPRESSED BY THE

AUTHORS OF INDIVIDUAL ARTICLES

DO NOT NECESSARILY REPRESENT

THE OFFICIAL VIEW OF BDMA

CONTENTS NATIONAL PRESIDENT'S MESSAGE

TRADE WAR OPENS EXPORTS OPPORTUNITY FOR INDIAN PHARMA COMPANIES 2

HYDERABAD: IMPORT OF VALSARTAN INTO COUNTRY STOPPED 3

PHARMACOS BAG 40% OF US GENERICS 3

PHARMA EXPORTS UP 3 PC TO USD 17.3 BN IN 2017-18 4

DOMESTIC PHARMA RETAIL MKT GROWS 13% IN JULY 4

INDIA AGEING FASTER THAN WE THOUGHT, SHOWS DATA 5

NPPA FIXES CEILING PRICE OF 92 DRUG FORMULATIONS 6

EUROPEAN SHARES DIP AS PHARMACEUTICALS' EARNINGS WEIGH 6

CHINA, KOREA OVERTAKING INDIA IN VACCINE EXPORTS: EXPERTS 7

‘REGULATORS NEED TO BE CAUTIOUS IN PHARMA INDUSTRY’ 8

MARKET ACCESS INITIATIVE SCHEME, 2018 8

SKILL DEVELOPMENT HIGHLIGHTS OF YEAR 2017-18 12

MINUTES OF 2ND MEETING OF INDIAN DRUGS / PHARMACEUTICALS ASSOCIATION 18

FORUM HELD ON 16.5.2018

SCHEME FOR DEVELOPMENT OF PHARMACEUTICALS INDUSTRY 19

GUIDELINES FOR IMPLEMENTATION OF THE FIVE SUB-SCHEMES UNDER THE SCHEME 24

FOR DEVELOPMENT OF PHARMACEUTICALS INDUSTRY

PHARMA EXPORTS FETCHED $17.27 BILLION IN THE PREVIOUS FISCAL AND THIS YEAR 29

IT WAS EXPECTED TO BE BETWEEN $19 BILLION AND $20 BILLION, PHARMACEUTICALS

EXPORT PROMOTION COUNCIL (PHARMEXCIL), DIRECTOR GENERAL UDAYBHASKAR SAID

PHARMALYTICA 2018 HIGHLIGHTS QUALITY CULTURE AND REGULATORY COMPLIANCE 30

TRENDS OF THE PHARMA SECTOR

USFDA OPENS DOOR TO DRUG IMPORT 30

CHINA READY TO SLASH INDIAN MEDICINE TARIFFS 31

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TRADE WAR OPENS EXPORTS OP-

PORTUNITY FOR INDIAN PHARMA

COMPANIES

He trade disputes between the US and

China have intensified lately, which can

potentially escalate to a full-fledged trade

war. While the rhetoric of verbal exchanges

between the two countries were on for some

time, the triggering action was the initiation of

a Section 301 case by the United States Trade

Representatives (USTR) against China's

intellectual property right (IPR) policies.

Earlier, in the month of April 2018, the USTR

proposed to impose an additional 25% tariff on

1,300 Chinese products valued at approximately $ 50 billion. This list included various

pharmaceutical products but the possibility

of a potential trade war in pharmaceutical

appears unlikely for now.

The US and China are dependent on each

other for the supply of pharmaceutical

products. The US imports considerable

quantities of Chinese active pharmaceutical

ingredients (bulk drugs) for the production of

finished dosage (formulations). China was the

second largest supplier of bulk drugs to the US

during 2016, accounting for a share of 12.8%.

Thus, the measure of imposing supplementary

tariffs would only contribute to massive

escalation in cost of US produced drugs.

Likewise, the US was the leading import source

of drug formulations for China during 2016, with

a share of 14.9%. China's imports of

formulations from the US recorded a CAGR of

13.8% during 2012 -2016. Clearly, there exists

substantial reliance between the two biggest

economies of the world for meeting their

respective domestic pharmaceutical needs.

Opportunities for exports to the US

The US is a leading pharmaceutical

market, with aggregate spending valued at $467

billion during 2017, and estimated to increase to

over $600 billion by 2022. It is the largest export

destination for the Indian pharmaceutical

market accounting for 12.5% share in case

of bulk drugs and 39.8% share in India's

exports of formulations.

Since India and China both are major import

sources of active pharmaceutical ingredients for

the US, the imposition of additional tariffs on

Chinese pharmaceutical products in future could

generate appreciable opportunities for Indian

exporters. China and India accounted for nearly

12.8% and 4.1% of the aggregate US bulk drug

imports during 2016. US imports of bulk drugs

from China and India during 2012- 2016 recorded a

CAGR of 1.4% and 4.5%, respectively. Therefore,

impending tariff rise on Chinese bulk drugs could

generate a surge in Indian bulk drug exports to

the US.

Opportunities for exports to China

The threat of increasing protectionist

measures may have also prompted China to open

up its market to Indian pharmaceutical industry.

During April this year, China exempted import

tariffs on 28 essential drugs including drugs for

cancer treatment. There are substantial

opportunities in the Chinese market, given that it

is the second largest pharmaceutical market – the

aggregate spending during 2017 was valued at

$123 billion, recording a healthy CAGR of 9.4%

during 2013-2017.

China's regulatory landscape is complex

and challenging due to incompatibility of China's

standards with that of the international ones and

relatively long time frame for approval of new

drugs. However, in 2017, various reforms were

introduced for promoting innovation and

diminishing the regulatory burden. The Chinese

FDA (CFDA) proposed the provision of conditional

approval for the urgently needed therapies and

orphan drugs, along with market access benefits

for new drugs. The policy reflects CFDA'S intent

to promote early launch of generic drugs to

improve their accessibility. These changes

present a positive outlook for major

pharmaceutical exporting nations such as India.

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While concession in tariff may bode well

for Indian exporters, non-tariff barriers have

been a greater challenge for exporters.

Moreover, the concessional tariff has not been

provided particularly for India, and can be

availed of by other exporting nations as well.

Thus, the removal of tariff alone might not have

remarkable impacts on exports; nevertheless

the tariff reduction accompanied by

implementation of regulatory reforms might

augment Indian pharma exports to China in the

future. The Indian pharma sector has to seize

this opportunity and mark its presence in the

worlds' second largest pharma market.

HYDERABAD: IMPORT OF VALSARTAN

INTO COUNTRY STOPPED

Hyderabad: Bulk drug companies in

Hyderabad have been notified by the Drug

Controller in Telangana against procuring active

ingredients for the chemical valsartan from China.

The import of this drug is being stopped

at all the ports across the country and drug

controllers have been asked to check the

chemicals which are being imported into India.

But the European Medical Agency alleges

that the contamination is since 2012. Hence, it

claims a lot of people have already been

exposed to the carcinogen. The bulk drug

manufacturers in India depend on China for

their active pharmaceutical ingredient. But the

processing into a tablet are carried out here.

A senior drug inspector on condition of

anonymity explained, “We require a dedicated

team to check on all the combination drugs

which have the chemical valsartan. It is also

used in generic drugs in India. Hence, a

massive checking needs to be carried out.”

For now the imports at the ports are

being monitored and adverse effects if any

are to be reported to the government.

PHARMACOS BAG 40% OF US GENERICS

A steady increase in drug approvals

and portfolio rationalisation by MNCs

resulted in India’s volume share rising by

5% over the last few months, though value

is still impacted due to price erosion.

The volume share of Indian pharma

companies in the US generic market has grown

to nearly 40% in August despite regulatory

woes and pricing pressures. A steady increase

in drug approvals and portfolio rationalisation

by MNCs resulted in India’s volume share rising

by 5% over the last few months, though value is

still impacted due to price erosion.

The US, the most lucrative generics

market valued at around $60 billion,

accounts for 40-60% of revenues of most

domestic companies — including Sun

Pharma, Cipla, Lupin and Aurobindo —

with an overall share of around $10 billion.

Over the last couple of years, channel

consolidation and deep pricing pressure has hit

generic companies, leading to biggies like Teva,

Mylan and Sandoz recently rationalising their

portfolio. This has given ground for Indian

companies to increase their hold in the US

market and it can continue to rise as the

portfolio rationalisation is far from over since

new (domestic) companies are still awaiting

approvals in base products, according to an

analyst from DSP Merrill Lynch India.

Planned portfolio exits from large MNC firms

have taken India’s volume share up 4 percentage

points in the last six months. Around 100 generic

drug discontinuations have already been registered

with the American regulator USFDA till now, largely

from these MNCs, with their share in the US market

plummeting to all-time lows — dropping to the level

of Indian generic makers. For example, Mylan’s latest

rolling four-week marketshare at 6.1% is already

neck and neck with Lupin and Aurobindo, while

market

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leader Teva is at 12.6% share — down 140 basis

points y-o-y (100bps = 1 percentage point).

The volume-led upside in certain

companies is not well reflected as yet, but will

soon drive growth in the near and mid-term,

and drive earnings 5-7% higher in FY19-20, the

analyst adds. Not only have drug approvals of

‘plain-vanilla’ generics surged in the US, but an

increasing number of domestic companies are

manufacturing ‘complex first generic’ products.

AT Kearney partner (healthcare and

pharma) Abhishek Malhotra says, “The first stage

of growth was based on leveraging India’s high-

quality and low-cost manufacturing base, and

primarily focused on generic drugs. Given the

pressure on pricing, increased competition and

higher regulatory scrutiny, many leading Indian

companies have embarked on the second leg of

the growth journey. This includes moving up the

value chain and developing more complex and

specialty drugs and acquiring US companies to

have manufacturing and R&D assets in the US.”

PwC India leader (pharmaceutical & life

sciences) Sujay Shetty says complex generics

and speciality products, which are difficult to

manufacture, and niche drugs could add value

for domestic companies in the near to mid-term

as they are more resilient to pricing pressure.

PHARMA EXPORTS UP 3 PC TO USD 17.3 BN IN 2017-18

Import alerts by the US Food and Drug

Administration, regulatory hurdles and currency

fluctuation also contributed to slow growth in the

overseas shipments, an industry expert said.

India's pharmaceutical exports grew

merely 3 per cent to USD 17.3 billion in 2017-

18 due to increasing regulatory concerns and

pricing pressures in the global markets,

including the US. The sector's exports in

2016-17 had declined to USD 16.7 billion as

against USD 16.9 billion in the previous

fiscal, according to commerce ministry data.

Import alerts by the US Food and Drug

Administration, regulatory hurdles and currency

fluctuation also contributed to slow growth in the

overseas shipments, an industry expert said.

The US is the top destination for Indian

pharma exports, followed by the UK. America

accounts for about 25 per cent of the

country's shipments. The other important

destinations include South Africa, Russia,

Nigeria, Brazil and Germany.

Although the government is working

on measures to promote exports in Japan

and China, tough registration and

regulatory procedures there act as

hindrance for domestic exporters.

The sector accounted for about 6 per

cent in the country's total exports of USD

303 billion in 2017-18. It is one of the top

five sectors in the exports segment.

Generic drugs form the largest segment

of the Indian pharmaceutical sector, with 75

per cent market share (in terms of revenues).

India supplies 20 per cent of global

generic medicines in terms of volume,

making the country the largest provider of

generic medicines globally.

Over 55 per cent of India's exports go to highly regulated markets.

Higher growth in outbound shipments helps

create employment opportunities, earn foreign

exchange and boost economic activities.

DOMESTIC PHARMA RETAIL MKT GROWS 13% IN JULY

The growth came on the back of higher

sales of anti-infectives, which rebounded

after a dip in June, while respiratory,

dermatology, and chronic therapies

continued to clock strong numbers. Mumbai: Domestic pharma retail market posted a

robust growth of nearly 13% in July indicating it

4

may be back on track after facing GST blues last

year. The growth came on the back of higher sales

of anti-infectives, which rebounded after a dip in

June, while respiratory, dermatology, and chronic

therapiescontinued to clock strong numbers. July

is the third month of consecutive growth after the

slump witnessed in the market over the past year.

The market, which had shown a degrowth of -2.4%

in July last year, has been on a recovery path

registering sales of 9% in June and nearly 11% in

May.

The market clocked Rs 10,616 crore in

July, buoyed by higher volumes (4.6%), price

increase (5.2%) and new launches (3%),

according to data from market research firm

AIOCD Awacs. Overall, 17 therapies registered

positive growth during the month, with chronic

therapies being star performers — anti-diabetic,

cardio and central nervous system up 18.5%,

15.5% and 14.2%, respectively. Sales of

dermatology jumped 18%, while gastro-

intestinal and vitamins gained nearly 11% and

13%, respectively, during the month.

Interestingly, price component has shown

a positive impact due to the GST rollout in 2017 — which had resulted in certain changes in

the pricing structure, while volumes have

also risen, the data shows. The July quarter

witnessed a volume growth of 6.6%, and

price growth of 1.2%, while new products

fared comparatively better at 2.8%.

Domestic companies registered a growth

of 13.4%, while MNCs were lower at 10.2% for

the month. Among the top 10 corporates, Lupin

showed the highest growth in the domestic

retail market at 19.6%, followed by Alkem

(17.8%) and Torrent (17.3%). Among MNCs,

Boehringer Ingelheim grew the fastest at 31.9%,

followed by Bayer (31.7%) and Astra Zeneca

(24%). Anti-diabetic therapy Mixtard by Abbott

continued to lead the pack among the top

brands, followed by Wockhardt’s painkiller

SpasmoProxyvon Plus, and diabetes medicine

Glycomet GP (USV) at the third slot.

Anti-diabetic therapy dominated the

pecking order with four of the top 10

brands, Galvus MET and Janumet being the

other top grossers

INDIA AGEING FASTER THAN WE THOUGHT, SHOWS DATA

India is greying faster than previously

projected, even though it fares better than other

Saarc countries and China. The government

has disclosed that the number of people above

60 will rise to around 340 million by 2050.

India is greying faster than previously

projected, even though it fares better than other

Saarc countries and China. The government

has disclosed that the number of people above

60 will rise to around 340 million by 2050.

The number, revealed by junior minister for

health Anupriya Patel in the LokSabha, is higher

than projections made by the United Nations (UN)

and other agencies, which also predict that the

elderly population will grow much faster than the

overall population with more old “widowed and

highly dependent women”. The UN projected the

60-plus population to grow to 316.8 million by

2050, whereas estimates by HelpAge India pegged

the number at 324 million.

Patel told the LokSabha on Friday that

the growth rate of the 0-14 population is

slowing but that of older people is rising. The

age distribution of India’s population is more

even as compared to China which has been

skewed by the one-child policy resulting in a

smaller and declining working age citizenry.

5

“India Ageing Report 2017” by the

United Nations Population Fund (UNFPA)

says the share of population over the age

of 60 could increase from 8% in 2015 to

19% in 2050. By the end of the century,

elderly will be 34% of the total population.

During 2000-2050, the overall population of

India is expected to grow by 56% while the

60-plus population will increase by 326%.

During the same period, the 80-plus

population will grow 700% with a

predominance of widowed and highly

dependent very old women. While India is

expected to report around 19% elderly by

2050, the absolute numbers will be very large.

Yet, India will be better off than China,

which is expected to report 34% of

population above 60 by 2050. According to

the report, a distinguishing feature in India

is a significant inter-state disparity.

For instance, southern states will have

more elderly, along with Himachal Pradesh,

Maharashtra, Odisha and Punjab. Central and

northern states have much lower proportions

of the elderly. Patel said the government is

taking steps to ensure care for the elderly.

NPPA FIXES CEILING PRICE OF 92 DRUG FORMULATIONS

"NPPA has fixed/revised ceiling

prices/ retail prices of 92 formulations

under Drugs (Prices Control) Order, 2013,"

it said in a notification.

Drug price regulator NPPA has fixed the

ceiling price for 92 drug formulations, including

those used for treatment of cancer, hepatitis C,

migraine and diabetes among others. The National

Pharmaceutical Pricing Authority(NPPA) said

while the retail price of 72 scheduled formulations

has been fixed, that of 9 has been revised. Further,

the authority has also revised the retail prices of

11 scheduled formulations.

"NPPA has fixed/revised ceiling prices/retail

prices of 92 formulations under Drugs (Prices

Control) Order, 2013," it said in a notification.

NPPA fixes the ceiling price of essential

medicines of Schedule I under the Drugs

(Prices Control) Order (DPCO) 2013. In respect

of medicines that are not under price control,

manufacturers are allowed to increase the

maximum retail price by 10 per cent annually.

The calculation for essential drugs is

based on the simple average of all

medicines in a particular therapeutic

segment with sales of more than 1 per cent.

Set up in 1997, NPPA has been

entrusted with the task of fixation/revision of

prices of pharma products, enforcement of

provisions of DPCO and monitoring of prices

of controlled and decontrolled drugs.

EUROPEAN SHARES DIP AS

PHARMACEUTICALS' EARNINGS WEIGH

Trading updates from Danish

drugmakers Novo Nordisk and Lundbeck

disappointed investors and their shares fell

5.2 percent and 8.7 percent respectively.

European shares dipped on Wednesday as

poor corporate earnings in the pharmaceutical

sector weighed on sentiment soured by trade

tensions, with Washington preparing tariffs on

another $16 billion of Chinese goods.

At 0910 GMT, the pan-European

STOXX 600 was down 0.2 percent with the

European healthcare index leading losers,

down 0.9 percent.

Trading updates from Danish

drugmakers Novo Nordisk and Lundbeck

disappointed investors and their shares fell

5.2 percent and 8.7 percent respectively.

Britain's UDG Healthcare also took a

hit, down 5.8 percent after flagging

weakness at its contract sales and patient

support services segment.

6

Other blue-chip results also weighed,

with Dutch food retailer Ahold Delhaize

down 1.9 pct and heavyweight miner and

trader Glencore retreating 1.6 percent.

Italian bank BPER Banca lost 5.6

percent, with one analyst citing

disappointing quarterly interest income.

French supermarket chain Casino

shed 8.5 percent after broker Bernstein cut

the stock to "underperform".

Among better received trading updates,

NokianTyres jumped 3 percent after beating

earnings expectations and Dutch bank ABN

Amro also added 3 percent after reporting

second-quarter profits.

Overall, STOXX 600 second-quarter

earnings are seen as encouraging and are

expected to increase 9.9 percent from the same

period last year, Thomson Reuters data shows.

A U.S. strong earnings season has also

fuelled optimism about economic strength

there, with S&P 500 firms seeing a 23.5 percent

rise in their April-June profits, according to

Thomson Reuters data. (Reporting by Julien

Ponthus; editing by John Stonestreet)

CHINA, KOREA OVERTAKING INDIA IN VACCINE EXPORTS: EXPERTS

Koreans and Chinese have become

aggressive, both were getting into the

markets of developed countries which India

has been exporting to, the sources said.

India, once called as the vaccine capital,

is slowly losing its sheen because of various

reasons, primarily the aggressive marketing

strategy of China and Korea and the lacklustre

policies of the government of India, say experts.

Vaccine exports from the country plunged

by eight per cent during 2016-17 and nearly four

per cent in the previous fiscal year.

India exported vaccines worth USD 653.40

million in 2017-18 while it was USD 679.28

million in 2016-17, according to data of the

Pharmaceuticals Export Promotion Council, a

body under the Ministry of Commerce.

Over 70 per cent of vaccines were exported

based on UNICEF requirement, which recently

changed its procurement policy from yearly indent

to quarterly, resulting in uncertainty over

production schedule, said chairman and

managing director of Bharat Biotech Krishna Ella.

The method adopted by the international

body on vaccine procurement gave an edge to

Korea and China on price bargaining resulting

in price erosion, Ella said.

Serum Institute of India, Bharat

Biotech and Biological E Limited were the

leading suppliers to UNICEF.

He said the government of India

needs to shed bureaucracy-centric policies

and develop science-oriented ones to

encourage vaccine-manufacturers.

"The country should have a strategy,

make policies and pricing transparent. Besides,

the government should sit with the industry and

take on China and Korea in the next five years.

If the government does not do that, we would

lose our grip on the vaccine market in another

two years," Ella told PTI.

According to industry sources, some of

the Korean companies such as LG Chem and

Samsung were spending millions of dollars

on expansion and modernising their facilities.

Koreans and Chinese have become

aggressive, both were getting into the

markets of developed countries which India

has been exporting to, the sources said.

When contacted, Director General of

PharmexcilUdayBhaskar said vaccine

constituted 3.78 per cent of the total

pharmaceutical exports last year.

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Though there has been a negative

growth of 10.25 per cent till February last

year, it recovered in March and ended up at

3.81 per cent, Bhaskar said.

‘REGULATORS NEED TO BE CAUTIOUS IN PHARMA INDUSTRY’

He said the state government had initiated

steps at administrative, legislative and

regulatory levels to check the menace of drugs.

Value of human life was more important than

anything else and thus there should be no

scope for escape of those compromising on

quality and efficacy, he added.

Chief minister Jai Ram Thakur while

interacting with the pharmaceutical and

cosmetics industry of Himachal Pradesh here

on Wednesday said regulators should be very

cautious while clearing the medicines from

quality and efficacy point of view. Besides,

regulatory framework should be strong enough

to have full control over quality parameters by

establishing well-equipped testing labs.

He said the state government had initiated

steps at administrative, legislative and

regulatory levels to check the menace of drugs.

Value of human life was more important than

anything else and thus there should be no

scope for escape of those compromising on

quality and efficacy, he added.

Thakur said pharma and cosmetic sectors in

the state were playing a vital role not only in

providing ample employment opportunities to the

youth of state but also strengthening economic

activities in the region. He said the basic amenities

such as roads, health, education and water supply

would be strengthened in the Baddi-Barotiwala-

Nalagarh belt in order to facilitate entrepreneurs.

He said the issue of change of land use for

industrial purpose would be considered

sympathetically in order to facilitate the

entrepreneurs. He said efforts would be made to

provide best transportation facilities to

industrialists to transport their products smoothly

to different parts of the country.

The chief minister said more such

interactive meetings would be held with

representatives of pharma industry for better

understanding and rapport. Health minister

Vipin Singh Parmar said the pharma industry

in the state was flourishing due to the special

industrial package announced in 2003.

MARKET ACCESS INITIATIVE SCHEME, 2018

1. Objective: A scheme to play catalytic

role for promoting exports and

addressing interventions required by

India for exploring new markets and

promoting export oriented activities

for commodities and services. 2. Scope: To provide financial support to

eligible agencies for undertaking various

market access initiatives delineated in the

Scheme including any direct/indirect

activities for marketing, market research,

capacity building, branding and statutory

compliances in importing markets. The

Scheme envisages to cover the scope of

both the erstwhile Market Access

Initiative Scheme and Marketing

Development Assistance Scheme. 3. Operation of the Scheme

3.1 Eligible Agencies: Unless otherwise

specified under a specific provision,

the scheme is open to the following

Organisations/Agencies:

C Departments of Central Government

and Organization of Central / State

Governments including Indian

Missions abroad C Export Promotion Councils C Registered Trade Promotion Organizations

C Commodity Boards under the Department of Commerce

C Apex Trade Bodies recognized under

Foreign Trade Policy of Government

of India

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C Recognized Industrial & Artisan Clusters C Individual Exporters (only where

specifically indicated) C National Level Institutions (e.g. Indian

Institute of Technologies (IITs), Indian

Institute of Management (IIMs), National

Institute of Designs (NIDs), NIFT etc.)

Research Institutions/ Universities/

Recognized laboratories, etc.

3.2. Criteria for Sanction 3.2.1 Market Access Initiatives (MAI) Scheme is

based on Market – Product/ Services

approach and the eligible agencies should

submit a comprehensive project for market

access on the basis of scientific analysis for

gaining market access under the various

provisions of the scheme. 3.2.2 To maximize the benefits of

participation in international fairs and

exhibitions, such efforts should be

linked with effective publicity campaign,

seminars, buyers-sellers meets etc. 3.2.3 Project proposals consisting of eligible

activities under the scheme would be

submitted to Department of Commerce

by the Eligible Agencies as per

procedure notified from time to time.

3.3. Scrutiny and Sanctions

3.3.1 There shall be an Empowered

Committee (E.C.) which will consider

and approve the proposals. The E.C.

will also monitor the implementation

of the sanctioned proposals. The

proposals approved by the EC shall

be individually processed for financial

sanction in accordance with approval

for sanction of funds as per laid down

procedure in the Government of India. 3.3.2 The EC shall, from time to time, issue

instructions/guidelines for administration

of the Scheme. A copy of Scheme

guidelines is at APPENDIX to the Scheme.

3.3.3 The composition of the Empowered

Committee shall be as under:

C Commerce Secretary – Chairman C Director General, DGFT – Member C Addl. Secy. & Financial Advisor, DoC

– Member C Director, Indian Institute of Foreign Trade

– Member C Representative of Secretary, MEA –

Member C Representative of Niti Aayog – Member C Economic Advisor, Department of

Commerce – Member C Representative of Secretary, M/o

MSME – Member C Joint Secretary, Administrative

Division for MAI, DoC - Convener C Jt. Secretaries of Commodity/ Territorial

Divisions in DOC/MOT– Special invitees 3.3.4 The Committee would meet as and when

required. To ensure ease of business,

the Committee may delegate its powers

to any Subordinate Committee to be

created for this purpose with

appropriate delegated powers, as may

be notified in the guidelines. 3.3.5 E&MDA Division, Dept. of Commerce, will co-

ordinate the work related to the Scheme and

liaise with Eligible Agencies for release and

utilisation of the sanctioned funds. 4. Level of Assistance: 4.1 The funding for each project will be on cost-

sharing basis with the sharing pattern

ranging from 65% to 50% at the minimum.

However, the Empowered Committee may

consider enhancement or curtailment of the

sharing pattern to permit for territorial or

product focus announced in the FTP. 4.2 The assistance shall be admissible for

the following components:

9

S.No. Component Eligible items of expenditure

1 Organising/ participating (i) Venue Cost, including organising expenses

in Fairs/ Exhibitions/ (ii) Publicity cost for the event

Buyer Seller Meets (iii) Cost of catalogue/ printed and digital material

abroad (iv) Translation and Interpreters charges

(v) Reimbursement of air-fare to exporting companies with

an f.o.b. value of exports below a notified threshold.

(vi) Expenditure towards freight charges for exhibits

(vii) Any other specific component approved by the

Empowered Committee.

2 Organising Reverse (i) Venue Cost, including organising expenses

Buyer Seller Meets (ii) Publicity cost for the event

[Made in India Shows] (iii) Cost of catalogue/ printed and digital material (iv) Translation and Interpreters charges

(v) Cost of air travel and hotel stay for foreign visitors

(vi) Any other specific component approved by the

Competent Authority.

3 Opening of Showrooms, (i) Lease/ rental charges of property for setting up of

Warehouses and Marketing showrooms/ warehouses/ marketing offices abroad for

Offices abroad and specific markets;

display in International (ii) Cost of setting up of showrooms/ warehouses

Departmental Stores (iii) Rental charges of display space at international

Departmental Stores or local distribution networks

4 Publicity Campaign and (i) Publicity campaigns for Commodities/ Services in

Cataloguing identified markets through various means

(ii) Catalogues of global standards for identified

Commodities/ Services for use in the markets of focus

5 Research and Product (i) Modernizing and upgrading facilities for developing

Development commodities of high technology value as per evolving trends in the global markets

(ii) Fees/ hiring charges for Technical Experts/Consultants/

Designers associated for such a project (The

consultation/ coordination charges not to exceed 2% of

the project cost.).

6 Capacity building for Support for setting up of Quality Certification Labs, Common

upgradation of quality Facility Centres, Design Centres in existing or upcoming hubs of Commodity/ Services sectors.

7 Capacity building of (i) Developing study material

exporters (ii) Organising training programmes for the trainers and exporters, including seminars/ workshops, etc.

(iii) Hiring consultants/ designers/ technical experts in the

export market for facilitating negotiations/ product

modifications as per local requirements

10

S.No. Component Eligible items of expenditure

8 Statutory compliances in (i) Registration charges paid in case of pharmaceuticals,

the buyer country bio-technology, chemicals/ agro-chemicals, agricultural/

animal/marine products, food products etc.

(ii) Expenses made for carrying out clinical trials; data

validation etc. for pharmaceutical products, equipments,

medical consumables/disposables etc.

(iii) Filing charges for market access in specified markets in

respect of Drug Master File (DMF) and Abbreviated New

Drug Application (ANDA) filing

(iv) Bio equivalence studies in India for pharmaceutical

exports;

(v) Filing of Patent and Capacity building / training related to

patent filing in respect of pharmaceutical products;

(vi) Testing charges of Engineering products (limited to

products indicated in FTP against EEPC India) which

require mandatory testing abroad for exports

(vii) Regulatory requirements for Services Sector

9 Anti-Dumping, Anti- Cost on contesting litigation (s) in the exporting market Money laundering and concerning restrictions/anti-dumping duties/CVD/SG duty

other investigations/ cases, as also Anti Money laundering Law compliances etc.

compliances on particular product (s) of Indian origin

10 Developing Foreign Creation of Trade Facilitation Portals for gathering market

Trade Facilitation Portals specific, product/ Services specific trade information

11 Market Studies (i) Market/ Product related studies aimed at facilitating greater market access

(ii) Export potential surveys for State

(iii) Studies relevant to JSG/ FTA/ RTA/ WTO along with other

studies relevant for bilateral or multilateral foreign trade

(iv) Any other study to further objective of the Scheme. 12 Any other activities, not

specified in the Scheme

As specified by the Empowered Committee and

consistent with scope and objective of the Scheme.

4.3 The quantum of assistance shall be as

notified from time-to-time in the guidelines. 5. Changes in Guidelines 5.1 Changes in approved Guidelines, if any,

would be with the prior approval of the

Empowered Committee. Such changes

may include modifications in individual

exporter-wise cap and overall ceiling

keeping in view the inflationary trend

and budget ceilings for MAI.

6. Monitoring and Review 6.1 To guide the Department/Implementing

agencies for optimal utilisation of

available resources, monitoring and

evaluation of sanctioned projects would

be undertaken. M&E would be designed

and implemented in collaboration with

reputed institutions, such as IIFT,

NCAER, ICRIER, IIMS, IITs, etc.

11

6.2 The Empowered Committee shall

periodically review the progress of the

scheme, to ensure achievements of the

objectives of the scheme and may lay

down guidelines for administering the

Scheme from time to time. The Committee

may authorize an outside agency to

undertake physical verification of projects

as may be decided on annual basis, to

ensure that the principles of canons of

financial discipline are maintained and

assets created are duly maintained. 6.3 The Eligible Agencies shall submit

such reports and such information as

is prescribed by Empowered

Committee in the Guidelines and/or

through executive instructions.

6.4 Empowered Committee would assign

necessary resources to ensure regular

Monitoring and Evaluation of projects,

not exceeding 2% of the annual Budget.

7. Scheme Validity

7.1 The Scheme is valid up to 31.03.2020.

SKILL DEVELOPMENT HIGHLIGHTS OF YEAR 2017-18

A Game Changer in Pharma

Manufacturing Skilling: Pharma VR

Simulation launched by LSSSDC

Skilling in Life Sciences (a high priority

Manufacturing sector) is a capital intensive

proposition, which few Training Partners can

afford. Being an export oriented sector, with 50%

revenue derived from exports, stringent USFDA

and EU regulations pose further challenges to

skilling candidates on the shop floor. To overcome

these constraints on skilling, especially for

manufacturing job roles, LSSSDC has developed

the GMP driven and SOP based Manufacturing

machine simulations for all the manufacturing

domains covering from API, Non sterile

formulation and sterile formulations.

By launching Virtual Reality Pharma

Manufacturing Plant, LSSSDC is changing the

landscape of Manufacturing Skill development

The simulation so developed with the help

of LSSSDC’s technology partner Simulanis and

LSSSDC’s Industry partners, is first of its kind in

India (and possibly the world) just because of its

scope and coverage. With the introduction of this

solution the Skill centre infrastructure cost has

been lowered to a fraction (one eightieth).

While approving the launch, a

Governing Body member of LSSSDC rightly

termed this as the “Future of Skilling in Life

Sciences Sector”……possibly any sector!

By end of March 2018, LSSSDC had already set up 4 skill centres equipped with Pharma VR Simulation Technology.

Mr. Ranjit Madan, CEO LSSSDC had stated that target for LSSSDC is to have at

least 2 VR simulation based skill centres in each industry cluster in the next 2 years.

Honourable Vice President of India inaugurates LSSSDC’s VR Simulation based Skill Centre in Hyderabad

Honourable Vice President of India Shri M Venkaiah Naidu inaugurating LSSSDC VR enable Skill Centre

12

On 18th March 2018, Honourable Vice

President of India Shri M Venkaiah Naidu

inaugurated LSSSDC's Virtual Reality

Simulation equipped Skill Centre at Swarna

Bharat Trust, our accredited TP in Hyderabad.

The Skill Centre at Swarn Bharat Trust was

earlier skilling only Manufacturing Assistant and

with the upgraded Skill Centre it aims at skilling

candidates for key manufacturing job roles like

Machine Operator & Production Chemist.

The Skilling at Swarn Bharat Trust is

completely funded by Granules India

through its CSR funds.

Granules India has expressed its

commitment in continuing its support to

Skill Development initiatives of LSSSDC.

LSSSDC Certified Students in

Manufacturing and Quality domain achieve

85% placement ratio

Manufacturing and QC verticals is average 85%.

Leading organizations who have hired

LSSSDC certified students were GSK,

Aurobindo, Hetero Drugs, Cadila Pharma,

Granules India, Sun Pharma and Abbott.

Recognition of Prior Learning (RPL):

Participation of large corporates in assessment

and certification of existing workforce

Following the DCGI advisory note to

Industry for need of getting existing workforce

assessed and certified by a third party national

level certification body like LSSSDC, Industry

after a series of deliberations and discussion

embraced the suggestion and has been

participating enthusiastically in getting their

existing workforce assessed and certified by

LSSSDC for relevant national qualifications.

Employees of Biological E during their Skill Certification felicitation ceremony by LSSSDC

LSSSDC certified candidates at SDI, Vishakhapatnam after their placement results

Being quality focussed, LSSSDC decided

not to set up the skill centres PAN India, and

decided to go for an Industry cluster approach—

especially for technical job occupations which

account for almost 75% of employment in sector.

Consequently, skilling activity which is fees based

(non PMKVY) in clusters of Life Sciences activity

involves local youth, who find placement in

Industry located in the cluster.

This has resulted in fruitful outcome for

those skilled and certified by LSSSDC.

Placement ratio in technical job roles, mostly in

In the past year over 18,000 enrolment

were received by LSSSDC and by end of

March 2018 close to 13,000 employed

workforce were assessed by LSSSDC.

Existing workforce in a MNC giant in Life Sciences

Sector during the RPL Skill Assessment

13

Major leading organizations like Abbott,

GSK, Merck, AstraZeneca, Sanofi, Lupin, DRL,

Aurobindo, Cadila Pharma, Glenmark,

Wockhardt, Alkem, Mankind, Biological E,

Granules India, Reckitt Benckiser, USV, Cargill,

Panacea Biotec, Bharat Serums, ACG Capsules,

Nectar Lifesciences, Naprod Group, Morepen,

Kumar Organics, Natco Pharma, Inogent,

Geltec, GNFC, DSM Sinochem have been

participating enthusiastically.

Pharmacy Council of India (PCI) joins

the Board of Life Sciences Sector Skill

Development Council

In an ongoing and continued effort to

include and involve all relevant stakeholders

in the skilling drive in Life Sciences Sector,

LSSSDC has joined hands with Pharmacy

Council of India (PCI), a highly reputed

Institution in Pharma domain.

All Industry leaders and Life Sciences

Industry Associations have welcomed this

move, which is expected to make fresh entrants

in Life Sciences Industry more job ready and

better equipped with required skill sets. LSSSDC focusses its effort for bridging the

Gap of Industry and Academia

In 2017-18, LSSSDC had been actively

engaging various Universities in its Skill

Development initiatives in Industry

Clusters for making the university students

equipped with appropriate skills required

by Life Sciences Industry.

All Universities engaged with LSSSDC are

either running the B. Voc. Programs under UGC

approvals or have launched add-on skilling

programs in the final year of graduation.

LSSSDC team supports these universities

with guidance on Curriculum, Skilling content

and even the faculty development programs.

Launch ceremony of Ramachandra University based Skilling Program at Chennai

Dr. B. Suresh, President PCI (Right) with Mr. Ranjit Madan, CEO-LSSSDC (Center) and Dr. Vadlamudi Rao, President, IPA

Dr B. Suresh, President PCI, being on

the Governing Body of LSSSDC effective

March, 2018 will be hugely beneficial to

Council’s activities and to students

pursuing Pharma degrees.

Universities taking the lead are Chitkara

University, Delhi University (AND College),

Sikkim University, Galgotia University,

Gujarat Technical University, Rayat Bahra

University, Calicut University, Mahrishi

Markandeshwar University, Amity University,

Indersheel University (Deemed to be).

CSIR-IICT launches Pratyancha- Skill

Development Program with APSSDC and

LSSSDC

14

CSIR-IICT Lab has launched its first of

its kind Skill Development Program named

“Pratyancha” in the month of Feb 2018.

This program is focussed on Skill

Development of fresh students for Life Sciences

Sector and is being supported by APSSSDC

(Andhra Pradesh Govt.) and LSSSDC.

Launch Ceremony of Pratyancha Program under APSSSDC-LSSSDC-CSIR-IICT

Under this program students will be

skilled for Bio Process Engineer, Quality

Control Chemist, QA Chemist Process

Validation, Quality Control Chemist-

Microbiology, QA Chemist Equipment

Validation, Research Associate- Product

Development/ Synthesis/ Medical Chemistry.

To begin with around 250 students are

being targeted for enrolment in first batches.

LSSSDC is providing the PMKVY

funding for Existing Workforce Skill

certification for MSME segment

Following the DCGI advisory note to

Industry for need of getting existing workforce

assessed and certified by a third party national

level certification body like LSSSDC, Council’s

Governing Board had felt the need of financial

assistance to MSME segment in Industry to

support them in this quality driven initiative.

To provide the financial assistance to the

MSME segment in Life Sciences Sector for the

purpose of assessment and certification of

employed workforce, LSSSDC Governing Board

(supported by DCGI) had requested MSDE to

allow the utilization of PMKVY fund and this

was accepted by Ministry.

To catalyse the efforts for skill

certification of workforce, LSSSDC is

empanelling various Project Implementation

Agencies (PIAs) who will be executing the

ground work of industry engagement of Mid,

Small and Micro Industry players PAN India.

Ministry of Skill Development and

Entrepreneurship empowers Sector Skill

Councils to engage Industry for

Apprenticeship under National

Apprenticeship Promotion Scheme

In recognition of the Industry connect

of Sector Skill Council’s and to catalyse the

Existing workforce in a MSME company in Life

Sciences Sector during the RPL Skill Orientation

and Assessment under PMKVY funding

15

Apprenticeship promotion in India, Ministry of Skill

Development and Entrepreneurship has decided to

empower Sector Skill Councils to engage Industry

for Apprenticeship under National Apprenticeship

Promotion Scheme (NAPS).

Soon all the CEOs of Sector Skill Councils

will be appointed as Joint Apprenticeship

Advisors under the Apprenticeship Act and will be

empowered to get into contract with Industry

directly for enrolment of Apprentices of the

students trained under PMKVY. They will also

have monitoring and certification responsibility.

NSDC is working on launching an

apprenticeship portal for Sector Skill Councils in

line to the current apprenticeship portal of DGET.

This move will enable Industry to

enrol more relevant apprentices, trained as

per qualifications and standards developed

by the Council.

Life Sciences Sector Associations

have welcomed the move and expressed

their support and commitment for

participation by their Industry members.

Visit us on WWW.LSSSDC.IN

Life Sciences Sector Skill Development Council

14, Palam Marg, 2nd Floor Rear, Vasant Vihar, New Delhi-110057, India

Phone No. +91 11 41042407/ 408/ 409/410 Write us on : INFO@LSSSDC.IN

16

Pre-Budget Memorandum to the Ministry of Finance, Central Government for Union Budget 2019-20.

Dear Members,

Members may be aware, the Government is contemplating preponing the timelines of the

Union Budget.

BDMA(I) intends to submit its recommendations latest by the Second week of September, 2018.

Timely submission of the Pre-Budget Memorandum is important and it is requested to

please send the proposals at the earliest and not later than 31 August, 2018. This will give

adequate time for preparation and also enable interaction, wherever necessary, before the

final Pre-Budget Memorandum is presented to the Ministry of Finance.

Suggestions are invited from members under three broad heads, namely:

- Direct Taxes - Indirect Taxes

• GST • Customs

- Policy Issues

The inputs should be in bullet points, precise and short, with factual data in word file, and

submitted in the following format:

Section / Subject Issue Rationale with factual data Recommendation

This would help ease of collation, and would ensure that no important concerns of the

industry are left out of the Pre Budget document.

Members are also requested to share the contact details (format given below) of the

person concerned for any clarification on the issues raised.

Area Handling Name Designation Email Phone

Direct Taxes

GST

Customs

Policy Issues

Look forward to receiving the inputs latest by 31 August 2018 by Email to: info@bdmai.org

17

MINUTES OF 2ND MEETING OF INDIAN

DRUGS / PHARMACEUTICALS ASSOCIATION

FORUM HELD ON 16.5.2018

Second meeting of Indian Drugs /

Pharmaceuticals Association Forum was

held on 16.05.2018 at FDA BHAWAN, New

Delhi to discuss primarily on the issues

relating to fixed dose combinations.

The list of participants is attached.

Dr. S. Eswara Reddy, DCG (I) welcomed

the participants and briefed about various

measures taken to streamline the regulatory

process including issues related to FDCs. He

requested the members to express their

views in this regard. Industry Associations

while appreciating the various regulatory

measures being taken by CDSCO and the

Ministry, highlighted the following issues: C To expedite the processing of applications

of FDCs falling under Category ‘b’ as per

C.K. Kokate Committee; C To clarify if any manufacturer who has

not been able to file the application

earlier in respect of FDCs considered

rationale by Committee can apply with

stability data and Form-29; C Whether SLA can directly give license in

respect of FDCs included in 294 list which

hava been considered rational by DTAB; C Issues relating to enforcement

activities / raids being conducted in

light of the fact that FDC matter is a

complex issue and interest of genuine

players should not be hampered. C Rationality of such FDCs may be considered

depending on whether it gives cost benefit,

compliance improvement to patients. C In case of FDCs which have been

considered irrational in general terms, may

be further examined to give guidance

whether such FDCs could be made rationale

by restricting / recommending its

specific dosage / strength, for specific

indication or other restriction on

manufacture / sale. Accordingly, based

on the recommendation, manufacturer

can rectify their product and come back

to the authority for approval.

DCG (I), after considering the view points of

the members mentioned that issue of processing

of FDCs examined / under examination by the

C.K.Kokate Committee as well as 294 FDCs is

being taken up with the Ministry of Health and

Family Welfare. Those manufacturers who have

not been able to file the applications earlier in

respect of rational FDCs, may be considered for

processing and approval subject to consideration

of the proposed pathway by the Ministry. It is also

being considered if applications in respect of

rational FDCs can be processed directly by the

SLAs for grant of manufacturing licence. However,

in such scenario, the Treasury Challan should be

submitted to Central Govt. as per the procedures

and copy of the Challan may be submitted to SLA

along with the application for verification.

FDCs falling under Category ‘b’ except

certain FDCs of Vitamin and minerals have already

been examined and categorized further into ‘a’ or

‘c’ or ‘d’ by the C.K.Kokate committee.

In respect of 294 FDCs, DCG (I) informed

that the list of these FDCs along with their

categorization have been uploaded on CDSCO

website. However, processing in respect of

these FDCs will be considered with approval of

the proposed pathways by the Ministry. DCG (I) also highlighted the need of

Pharmaceuticals Data Management and

requested that all industry associations should

be proactive and sensitize their members to

upload the information in respect of

manufacturing licences, marketed products etc.

within three months. CDSCO is going to upload

the module prepared in this regard so that the

industry can upload the data proactively.

The meeting ended with vote of thanks to the Chair

18

List of the participants of second Indian

Durgs / Pharmaceuticals Association

Forum held on 15.05.2018 at FDA Bhawan,

New Delhi.

S.No. Name of the Participants 1 Dr. S. Eswara Reddy, DCG (I), CDSCO

2Dr. V.G. Somani, JDC (I), CDSCO

3Dr. K. Bangarurajan, JDC (I), CDSCO

4Mr. A.C.S. Rao, DDC (I), CDSCO

5Mr. A K Pradhan, DDC (I), CDSCO

6Dr. S. Manivanan, DDC (I), CDSCO

7Mr. Ranga Chandrashekhar, DDC (I), CDSCO

8Mr. Ankit Sharma, ADC (I), CDSCO

9Mr. Rishi Kant, Legal Consultant, CDSCO

10 Mr. Navneet Marwaha, DC, Himachal Pradesh

11 Mr. Dilip G. Shah, IPA

12 Dr. Rajesh Jain, IPA

13 Mr. Gulshan Kumar, IPA

14 Mr. Deepnath Roy Chowdhury, IDMA

15 Mr. R.K. Sanghavi, IDMA

16 Mr. S.M. Mudda, IDMA

17 Mr. Ashok K Madan, IDMA

18 Mr. Rajesh Gupta, Laghu Udyog Bharati

19 Mr. Goving Lele, Laghu Udyog Bharati

20 Mr. Atul Shah, Laghu Udyog Bharati

21 Mr. P.K. Gupta, CIPI

22 Mr. R.K. Jain, CIPI

23 Mr. D.C. Jain, CIPI

24 Mr. R.C. Juneja, FOPE

25 Mr. B.R. Sikri, FOPE

26 Ms. Aprajita Takiar, FOPE

27 Mr. Sudesh Kumar, FOPE

28 Mr. R.K. Rustagi, FOPE

SCHEME FOR DEVELOPMENT OF PHARMACEUTICALS INDUSTRY

The Department of Pharmaceuticals has

prepared a Scheme for Development of

Pharmaceuticals Industry with the objective to

ensure drug security in the country by increasing

the efficiency and competitiveness of domestic

pharmaceutical industry with the following sub-

schemes: (a) Assistance to Bulk Drug Industry for

Common Facility Centre; (b) Assistance to

Medical Device Industry for Common Facility

Centre; (c) Pharmaceuticals Technology

Upgradation Assistance Scheme (PTUAS);(d)

Assistance for Cluster Development; and (e)

Pharmaceutical Promotion Development Scheme

(PPDS). The said scheme is a Central Sector

Scheme with a total financial outlay of Rs. 480

Crore. The guidelines for implementation of the

sub-schemes are uploaded on the website of the

Department.

The details of the sub-schemes are as

follows:

i. Assistance to Bulk Drug Industry for

Common Facility Centre:

Under the sub-scheme, financial assistance

would be provided for creation of common

facilities in any upcoming Bulk Drug Park

promoted by State Governments/State

Corporations. The Scheme would be implemented

through a one-time grant-in-aid to be released to a

State Implementing Agency (SIA) set up for the

purpose. Some of the indicative activities under

the Common facilities include Effluent Treatment

Plants, Captive Power Plants, Steam and Cooling

systems, Incubation facilities, Common logistic

facilities, Advance common testing Centre,

Regulatory awareness facilitation Centre and

Emergency Response Centre. A total of Rs. 200

Crore has been earmarked for the scheme. The

maximum limit for the grant in aid under this

category would be Rs. 100 Crore per Bulk Drug

Park CFC or 70% of the project cost of CFC

whichever is less.

19

ii. Assistance to Medical Device Industry

for Common Facility Centre:

Under the sub-scheme, financial assistance

would be provided for creation of common

facilities in any upcoming Medical Device Park

promoted by State Governments/ State

Corporations. The Scheme would be implemented

through a one-time grant-in-aid to be released to a

State Implementing Agency (SIA) set up for the

purpose.Some of the indicative activities under

the Common facilities include Component Testing

Centre, Electro-magnetic interference laboratory,

Biomaterial / Biocompatibility testing centre,

Medical grade low vacuum moulding, Cabinet

moulding injection moulding centers, 2D

designing and printing for medical grade

products, Sterilization and Toxicity testing centre,

Radiation testing centre, etc. A total of Rs. 100

Crore has been earmarked for the scheme. The

maximum limit for the grant in aid under this

category would be Rs. 25 Crore per Medical

Device Park CFC or 70% of the project cost of CFC

whichever is less.

iii. Pharmaceuticals Technology

Upgradation Assistance Scheme

The objective of the sub-scheme is to

facilitate Small and Medium Pharma Enterprises

(SMEs) to upgrade their plant and machinery to

World Health Organization (WHO)/Good

Manufacturing Practices (GMP) standards so as to

enable them to participate and compete in global

markets. Assistance in the form of interest

subvention against sanctioned loan by any

scheduled commercial bank/financial institution,

both in Public and Private sector will be provided

to 250 pharma SMEs of proven track record. The

Scheme is implemented through a Public Sector

Financial Institution (PSFI) to be identified by the

Government. A total of Rs. 144 Crore has been

earmarked for the scheme. The upper limit of

interest subvention on loans for technology/

infrastructure upgradation shall be restricted to

6% per annum for a period of three years on

reducing balance basis. The maximum loan

eligible for this purpose will be Rs. 4 Crore,

availed by the concerned SME.

iv. Assistance for Cluster Development

This is an existing and approved scheme of

the Department (Cluster Development Programme

for Pharma Sector (CDP-PS)) now being

subsumed under the umbrella scheme. Under the

Scheme, financial assistance would be provided

for creation of common facilities in any pharma

clusters including Bulk Drug, Medical Device,

Ayurvedic, Unani and Cosmetics Units. Some of

the indicative activities under the Common

facilities include Common Testing Facilities,

Training Centre, R&D Centres, Effluent Treatment

Plant and Common Logistics Centre. The Scheme

would be implemented on a Public Private

Partnership (PPP) format through one time grant-

in-aid to be released in various to a Special

Purpose Vehicles (SPVs) set up for the purpose. A

total of Rs. 30 Crore has been earmarked for the

scheme including Rs. 10 Crore which was

allocated in 2017-18. Maximum limit for the grant

in aid under this category would be Rs 20.00 Crore

per cluster or 70% of the cost of project whichever

is less.

v. Pharmaceutical Promotion Development Scheme

This is an existing and approved scheme of

the Department now being subsumed under the

umbrella scheme. The scheme aims at the

promotion, development and export promotion in

Pharmaceutical sector by extending financial

support for conducting seminars, conferences,

exhibitions, mounting delegations to and from

India for promotion of exports as well as

investments, conducting studies/ consultancies,

for facilitating growth, exports as well as critical

issues affecting Pharma sector. A total of Rs. 6

Crore has been earmarked for the scheme.

20

F.No.22-65/2017-IA.III Government of India

Ministry of Environment Forest and Climate Change Impact Assessment Division

Indira Paryavaran Bhawan Jor Bagh Road, Aliganj

New Delhi - 110003.

Dated : 1st May, 2018

Office Memorandum

Sub : Corporate Environment Responsibility (CER) - reg.

1. The Environment Impact Assessment (EIA) Notification, 2006, issued under the

Environment (Protection) Act, 1986, as amended from time to time, prescribes the

process for granting prior environment clearance (EC) in respect of certain

development projects/activities listed out in the Schedule to the Notification.

2. Sustainable development has many important facets/components like social, economic,

environmental, etc. All these components are closely inter-related and mutually re-

enforcing. Therefore, the general structure of EIA document, under Appendix-III to the

notification, prescribes inter-alia public consultation, social impact assessment and R&R

action plan besides environment management plan (EMP).

3. Section 135 of the Companies Act, 2013 deals with Corporate Social Responsibility (CSR) and

Schedule-VII of the Act lists out the activities which may be included by companies in their

CSR Policies. The concept of CSR as provided for in the Companes Act, 2013 and covered

under the Companies (Corporate Social Responsibility Policy) Rules, 2014 comes into effect

only in case of companies having operating projects and making net profit as also subject to

other stipulations contained in the aforesaid Act and Rules. The environment clearance given

to a project may involve a situation where the concerned company is yet to make any net

profit and /or is not covered under the purview of the aforesaid Act and Rules. In such cases,

the provisions of aforesaid act and Rules will not apply.

4. In the past, it has been observed that: different Expert Appraisal Committees / State

Expert Appraisal Committees (EACs/SEACs) have been prescribing dirrerent

formulation of the Corporate Environment Responsibility (CER) and no common

principles are followed. Several suggestions have also been received in this regard

which inter-alia states that Greenfield projects and Brownfield projects should be

treated differently; no CER should be prescribed whereas there is no increase in air

pollution load, R&R etc., besides streamlining percentage of CER.

21

5. The Ministry has carried out a detailed stakeholder consultator which inter-alla included

meeting with Ministry of Petroleum & Natural Gas, Ministry of Power, Chairmen EACs,

FICCI, ASSOCHAM, Gujarat Chamber of Commerce and Industry amongst others.

6. In order to have transparency and uniformity while recommending CER by Expert

Appraisal Committee (EAC) / State level Expert Appraisal Committee (SEAC) / District

level Expert Appraisal Committee (DEAC), the following quidelines are issued:

(i) The cost of CER is to be in addition to the cost envisaged for the implementation of

the EIA/EMP which includes the measures for the pollution control, environmental

protection and conservation, R&R, wildlife and forest conservation/protection

measures including the NPV and Compensatory Aforestation, required, if any, and

any other activities, to be derived as part of the EIA process.

(ii) The fund allocation for the CER shall be deliberated in the EAC or SEAC or

DEAC, as the case may be, with a due diligence subject to maximum

percentage as prescribed below for different cases:

S.No. Capital Investment / Greenfield Project - % of Brownfield Project - %

Additional Capital Investment Capital Investment of Additional Capital

(in Rs) Investment

I II III IV

1. < 100 crores 2.0% 1.0%

2. > 100 crores to < 500 crores 1.5% 0.75%

3. > 500 crores to < 1000 crores 1.0% 0.50%

4. > From 1000 crores to < 0.5% 0.25%

10000 crores

5. >10000 crores 0.25% 0.125%

(iii) The activities proposed under CER shall be worked out based on the issues

raised during the public hearing, social need assessment, R&R plan, EMP, etc.

(iv) The proposed activities shall be restricted to the affected area around the project.

(v) Some of the activities which can be carried out in CER, are infrastructure

creation for drinking water supply, sanitation, health, education, skill

development, roads, cross drains, electrification including solar power, solid

waste management facilities, scientific support and awareness to local farmers

to increase yield of crop and fodder, rain water harvesting, soil moisture

conservation works, avenue plartation, plantation in community areas, etc.

(vi) The entire activities proposed under the CER shall be treated as project and

shall be monitored. The monitoring report shall be submitted to the regiona

office as a part of half-yearly compliance report, and to the District Collector. It

should be posted on the website of the project proponent.

22

(vii) The District Collector may add or delete the activities as per the requirement of

the District.

(viii) The EAC can vary the above percentage of CER subject to proper diligence,

quantification and justification. The EAC based on appraisal, should clearly

suggest the activities to be carried out under CER. (ix) This CER is not applicable in name change, transfer and amendment involving

no additional project investment. In case of amendment in EC involving

additional expenditure, CER will be applicable only on the additional

expenditure as per column-IV of the table given in para 6 (II) above.

7. This issues in supersession of all earlier OMs and guidelines issued in this regard.

8. This issues with the approval of competent authority.

(Sharath Kumar Pallerla) Director (IA-III-Policy)

1. Chairman, CPCB 2. Chairmen of all the Expert Appraisal Committees 3. Chairperson/Member Secretaries of all the SEIAA/SEACs 4. Chairpersons/Member Secretaries of all SPCBs/UTPCCs 5. All the officers of IA Division

Copy for information to :

1. PS to Minister for Environment, Forest and Climate Change 2. PS to MoS (EF&CC) 3. PPS to Secretary (EF&CC) 4. PPS to AS (AKJ) / AS (AKM) 5. PPS to JS (GB) / JS (JT) 6. Website, MoEF&CC 7. Guard File.

23

GUIDELINES FOR IMPLEMENTATION

OF THE FIVE SUB-SCHEMES UNDER

THE SCHEME FOR DEVELOPMENT OF

PHARMACEUTICALS INDUSTRY

(A) Assistance to Bulk Drug Industry for

Common Facility Centre

(1) Objective (i) Increasing the competitiveness, easy

access to standard testing and

infrastructure facilities and value addition in

the domestic Bulk Drug Industry through

creation of common world class facilities.

(ii) Strengthening the existing

infrastructure facilities in order to

make Indian Bulk Drug Industry a

global leader in Bulk Drugs’ Exports. (iii) Reducing the cost of production by

20-25% in the Bulk Drug Park leading

to better availability and affordability

of Bulk Drugs in domestic market. (iv) Exploiting the benefits arising due to

optimization of resources and

economies of scale.

(2) The Scheme

(i) The Scheme termed as Development

of Common Facility Centre for Bulk

Drug (DCFC-BD) is proposed as a

Central Sector Scheme. (ii) The total size of the scheme is

proposed as Rs. 200 Crores for DCFC-

BD for 2018-2020. (iii) The Scheme would be implemented

through a one-time grant-in-aid to be

released for creation of identified

infrastructure and common facilities

to a State Implementing Agency (SIA)

set up for the purpose.

(iv) The purpose of the grant is to render the

financial assistance for establishment of

common facilities in any upcoming Bulk

Drug Park promoted by State

Governments/State Corporations.

(v) The various aspects and outcomes of

the Scheme will be reviewed by the

SSC in DoP, after two years from the

date of its initiation.

(3) Scope and Coverage

Assistance under the Scheme will be

admissible for creation of common

facilities in Bulk Drug Park. (4) Common Facilities

A State Implementing Agency (SIA)

should be set up to take a decision about

the Common Infrastructure facilities

needed to be created for being eligible to

be considered as a Common Facility

Centre (CFC) for a Bulk Drug Park. Such

assessment will depend upon the nature

of manufacturing projects likely to be set

up in any selected Bulk Drug Park.

Common Facilities under the sub-scheme

will consist of creation of tangible

"assets" as Common Facility Centres

(CFCs). Some of the indicative activities

under the Common facilities are:-

(i) Effluent Treatment Plants (ii) Captive Power Plants (iii) Steam and Cooling systems (iv) Incubation facilities (v) Common logistic facilities (vi) Advance common testing Centre (vii) Regulatory awareness facilitation Centre

(viii) Emergency Response Centre

24

The Scheme Steering Committee (SSC) in

the Department of Pharmaceuticals (DoP)

shall approve the project components

and funding thereof depending upon the

merits of the proposal.

(i) The land and building for CFC shall

be provided by SIA concerned as per

cost indicated. (ii) The CFC should be operationalized within

two years from the date of final approval,

unless extended with the approval of

Scheme Steering Committee (SSC).

(iii) Escalation in the cost of project over

and above the sanctioned amount,

due to any reason, will be borne by

the SIA. The Central Government shall

not accept any financial liability

arising out of operation of any CFC. (iv) User charges for services of CFC

shall be on differential rate basis,

lower fee for small units and higher

fee for medium ones. However, the

user charges will be graded in such a

manner that average charges will be

lesser than prevailing market prices

to be decided by the concerned SIA. (v) A Tripartite Agreement shall be entered into

among the GOI, the State Government

concerned and the SIA for CFC projects.

(5) Eligibility

(i) State Implementing Agency

It is necessary to form a SIA prior to

setting up of and running the proposed

CFC. An SIA is a clear legal entity set

up by the State Government for

implementing the Bulk Drug Park

Project and responsible for the day to

day management of the Bulk Drug Park. (ii) Detailed Project Reports (DPR)

A Detailed Project Report (DPR) has to

be prepared by the SIA and submitted

to the Department of Pharmaceuticals

(DoP) as the first and foremost activity

for availing assistance under this sub-

scheme. The DPR should have details

of all the business processes of the

Bulk Drug Parks viz. manufacturing

process, technology, marketing, quality

control, testing, purchase, outsourcing,

etc. to identify impediments and

bottlenecks; and to draw action plan for

enhancing competitiveness of the units

to be set up in the Bulk Drug Parks.

(6) Financial Assistance (i) Maximum limit for the grant in aid under

this category would be Rs. 100 Crores per

Bulk Drug Park CFC or 70% of the project

cost of CFC whichever is less. The cost of

project includes cost of Land, building,

pre-operative expenses like preparation

of DPR, administrative and management

support expenses including the salary of

CEO, engineers, other experts and staff

during the project implementation period,

preliminary expenses, machinery &

equipment, miscellaneous fixed assets

and other support infrastructure such as

water supply, electricity and margin

money for working capital.

(ii) Assistance for Administrative and

other management support of SIA

including the salary of CEO for the

project implementation period shall

not exceed 5 % of the Grant-in-aid. (iii) Assistance for engaging engineers and

other experts for execution of civil works

shall not exceed 5% of the Grant in Aid.

(iv) Necessary infrastructure like land, access

road, water and power supply, etc. must be

in place or substantial progress should

25

have been made in this regard before GoI

assistance is released. Where bank finance

is involved, written commitment of the bank

concerned to release proportionate funds

will also be necessary before release of GoI

assistance.

(v) Funds will be released in instalments

depending upon the implementation plan,

requirements of funds and as approved

by the Scheme Steering Committee (SSC).

(7) Other Requirements of Common

facility Centres

In addition to foregoing, any proposal

prepared under the scheme should

meet the following:-

(i) It shall be the responsibility of the SIA

to bring in land as its contribution; (ii) The CFC set up with the financial

assistance under this scheme should be

economically viable so as to generate

adequate revenue for its sustenance.

(8) Time Frame for CFC Project

Implementation

The time frame for implementation of

a SSC approved CFC project would be

2 years from the date of its approval. (9) State Implementing Agency

(i) Although SIA/Project Implementing

Agency would fulfil the requirements as

decided by SSC to avoid any conflict of

interest and smooth implementation

and operation of the project, however

the broad activities and roles assigned

to the SIA would be as follows:

(a) Prepare the Detailed Project Report

covering the technical, financial,

institutional operational aspects of

the CFC projects.

(b) Raise balance amount of Project cost. (c) Obtaining any statutory approvals/

clearances including release of funds. (d) Recruit suitable functional

professionals in order to ensure that

the project is executed smoothly. (e) Implement various interventions as

outlined and approved in DPR. (f) To furnish regular progress report

directly to Department of

Pharmaceuticals (DoP) and SIA shall

have the following responsibilities:- (i) Appraisal of the DPRs indicating financial

viability, commercial sustainability and

socio-economic impact for according

final approval to the projects.

(ii) Assist DoP in formulating a suitable

strategy for implementation of the scheme.

(iii) Assist the DoP in periodical monitoring the

progress of the projects, and disbursement

of funds and their utilisation.

(10) Role of State Governments

The State Government is envisaged to play

a pro-active role in the following areas:-

(a) Promoting the Bulk Drug Park aggressively

at National & International level.

(b) Undertaking equity stake in the SIA. (c) Providing the necessary assistance for

external/ access infrastructure as land,

access road, Power and Water supply etc.

(d) Providing flexible and conducive

environment and consider special

facilities like exemption of stamp duty

etc. for the SIA/ individual Bulk Drug

units to be set up in the Park.

26

(e) Providing necessary project related

clearances expeditiously

(11) Implementation Framework

Scheme Steering Committee (SSC)

The Department of Pharmaceuticals (DoP)

will provide overall policy, coordination

and management support to the Scheme.

The proposals under the scheme will be

considered for approval by the Scheme

Steering Committee (SSC) of DCFC-BD.

The composition of the Scheme

Steering Committee will be as follows:-

i. Secretary, DoP - Chairperson ii. Financial Adviser, DoP-Member iii. Joint Secretary, M/o EF&CC-Member iv. Joint Secretary, D/o IPP-Member v. Joint Secretary, M/o H&FW-Member

vi DCGI, CDSCO- Member vii Representative of State Implementing

Agency (SIA)- Member vii Joint Secretary(Policy), DoP-Convenor

The SSC may co-opt representatives

of Industry Associations, R&D

Institutions and other Government/

Private sector expert organizations as

members or special invitees as may

be necessary from time to time.

(12) Project Approval for setting up of CFC

The SSC shall approve the projects and

also monitor their implementation.

There would be two-stage process for

approval of the projects viz. ‘In-

principle’ approval and final approval.

(a) In-principle approval

In -principle approval for a project will be

accorded by the SSC based on

preliminary proposal submitted by the

SIA/State Government covering the major

features of the proposed project and

availability of land. Such in -principle

approval will be valid for a period of 6

months from the date of approval. Before

that, it is expected that the project would

be ready for final approval. In case final

approval is not accorded to the project

within 6 months, in-principle approval will

automatically lapse, unless it is

specifically extended by the SSC.

(b) Final Approval

A project will be accorded final

approval by the SSC if the following

conditions are fulfilled:

i. Establishment of project specific SIA; ii. Procurement of requisite land by the SIA;

iii. Preparation of DPR by SIA and its

appraisal by SSC iv. Opening of separate bank account for

the purpose by the SIA with any

scheduled commercial bank. The

funds to be released by Department of

Pharmaceuticals, Government of India

under this sub-scheme shall be

transferred to the said account of SIA. v. Tying up of sources of funds for the

balance amount.

(13) Guidelines for Release of Funds

Based on the DPR and the nature of

the project, detailed guidelines in

respect of implementation of the

project and subsequently release of

funds by the Department will be

prepared by the SIA and approved by

the Scheme Steering Committee

(SSC) in the following manner:-

27

Instalment Percentage of Funds Remarks/ Pre-requisite

1. 30 • mobilization advance against an Indemnity Bond, on

final approval of the project by SSC

2. 30 • against the production of Bills

• the utilisation of at least 60% of the 1st instalment

and after the proportionate expenditure has been

incurred by the SIA

3. 30 • against the production of Bills

• 100% utilisation of 1st instalment and at least 60%

utilization of 2ndinstalments and after the

proportionate expenditure has been incurred by the

SIA

4. 10 • SIA has mobilized and spent its entire share in

proportion to grant

The SIAs shall submit the Utilisation

Certificate (UC) for the amounts

utilized as per the format in

accordance with GFR 12A;

Accounts of SIA shall be subject to

audit by the Comptroller & Auditor

General of India.

(14) Maintenance /Ownership of Assets

(i) SIA shall be responsible for O&M of

assets created under the scheme by

way of collecting user charges from

the members/ users; (ii) The Assets acquired by the SIA out of

government assistance shall not be

disposed, encumbered or utilized for

the purposes other than for which the

funds have been released. (iii) A register of permanent and semi-

permanent assets acquired wholly or

mainly out of the funds provided by GOI

should be maintained as per GFR.

(iv) If for any reason SIA is liquidated,

Government of India will have the first right

to recover the grant funds provided by it.

The assets created with such grant funds

and any unutilized fund shall be vested with

the Central Government. The Memorandum

of Association & Articles of Association of

the SIA with the Government shall

incorporate this condition.

(15) Miscellaneous Provisions

15.1 Monitoring and Management Expenses:

Project monitoring and management

expenditure will be limited to maximum

1% of the total budget outlay of the

sanctioned funds will be utilised. The

main activities for which these funds

will be utilized include, mainly in DoP:-

(i) Preparation of panels of Pharma

Regulatory Affair Experts/Agencies

for preparation of Detailed Project

Report for assistance for eligible

activities in the Bulk Drug Park. (ii) Expenditure involved in site visits of the

Bulk Drug Park for monitoring of

progress and evaluation of the scheme.

(iii) Development of customized software

for data management, specialized

reports, monitoring and evaluation.

28

(iv) Bulk Drug Park related publicity

material for awareness generation. (v) Organization of meeting of various

Committees including the Scheme

Steering Committee (SSC). (vi) Purchase of office automation equipment

like photocopier, maintenance etc. (vii) Outsourcing of Data management

services.

PHARMA EXPORTS FETCHED $17.27 BILLION IN THE PREVIOUS FISCAL AND

THIS YEAR IT WAS EXPECTED TO BE

BETWEEN $19 BILLION AND $20 BILLION, PHARMACEUTICALS

EXPORT PROMOTION COUNCIL

(PHARMEXCIL), DIRECTOR GENERAL

UDAYBHASKAR SAID.

Pharmaceutical exports from the

country are expected to cross $19 billion in

worth during the current fiscal despite

muted growth in the North American

markets, according to Pharmexcil, a body

under Union Commerce Ministry.

Pharma exports fetched $17.27 billion

in the previous fiscal and this year it was

expected to be between $19 billion and $20

billion, Pharmaceuticals Export Promotion

Council (Pharmexcil), Director General

UdayBhaskar said.

During the first quarter of the current fiscal,

pharma exports clocked an increase of 17.76

percent to $4.6 billion against $3.9 billion during

the corresponding quarter a year ago, he said.

"Last year we had 2.92 percent growth in

Pharma exports. We are expecting that we may

reach $19 billion to $20 billion in the year 2018- 19. Old markets are getting revived and we

are also entering into new markets," said

Mr. Bhasker.

He said most of the issues with regards to

the United States Food and Drug Administration

(USFDA), which had impacted exports from

India in the first five months of last fiscal, were

getting resolved. "Chinese market is also

opening up. We are working on that. China has

removed tariff on certain cancer drugs. All

these create conducive atmosphere for Indian

drug exporters," he said.

Bhaskar said Pharmexcil had been

advising drug manufacturers in the country to

look for emerging markets to offset the US

impact. North America, the largest market for

Indian Pharma exporters, witnessed a negative

growth of 7.35 percent to $5.35 billion in FY 18

against $ 5.77 billion in the previous year.

It constitutes over 30 percent of Indian

pharma exports followed by Africa and the

European Union with 19.37 percent and 15.92

percent respectively. However, during the

first quarter ending June 30, exports to North

America registered 17.67 percent growth to $

1.40 billion, Bhaskar added.

Bhaskar said that Pharmexcil was also

taking a business delegation to China later

this month to tap the potential of the Asia's

largest economy following some regulatory

changes in the neighbouring country. "China

made zero duty on anti-cancer drugs. They

also simplified product registration

procedures... there are some proactive steps

by the Chinese Government," he said.

Pharma exports to China during the last

fiscal registered a growth of over 37 percent to $

29

200 million against $145.5 million in 2016-

17, according to Pharmexcil statistics.

PHARMALYTICA 2018 HIGHLIGHTS

QUALITY CULTURE AND

REGULATORY COMPLIANCE TRENDS

OF THE PHARMA SECTOR

The event witnessed a participation

from over 150 exhibitors from across the

country.

(L-R- UdayBhaskar Reddy, Director General,

PHARMEXCIL; Yogesh Mudras, Managing

Director, UBM India; Dr R B Smarta, MD, Interlink

Marketing Consultancy; AvinashTalwar, Director &

Head, Global Sourcing (Strategic & Plant) Dr.

Reddy's Laboratories Ltd)

UBM India, the organisers of CPhI / P-MEC

India, the leading global pharma trade show and

conference, recently hosted the 5th edition of

PharmaLytica 2018 in Hyderabad at the HITEX

Exhibition Centre, with BioSpectrum serving as

the conference partner. The two day event, 10-11th

Auguest 2018, was inaugurated by Dr.

PreetiMeena IAS, Director, Drugs Control

Administration, Hyderabad along with Mr.

UdayBhaskar Reddy, Director General,

Pharmaceuticals Export Promotion Council

(PHARMEXCIL); Dr. P V Appaji, Director General

Emeritus, Pharmaceuticals Export Promotion

Council (PHARMEXCIL); Mr. AvinashTalwar,

Director & Head, Global Sourcing (Strategic &

Plant) Dr. Reddy's Laboratories Ltd, Dr. R B

Smarta, MD, Interlink Marketing Consultancy, Mr.

Yogesh Mudras, Managing Director, UBM India

and Mr. Rahul Deshpande, Group Director,

UBM India amidst an industry gathering.

During the inaugural ceremony,

UdayBhaskar Reddy stated, "In FY 2017-18,

Indian Pharma exports grew to $ 17.26 billion.

One of the key development to notice is,

despite 8% negative growth witnessed in the US

market, we still grew positive by 2.92%. There

are potential markets to explore like China,

South Africa and CIS markets and even if

negative growth continues in the US market, the

Indian Pharma companies should be confident

and focus on growth and explore opportunities

in the potential markets”.

The two day event saw brainstorming

sessions by industry experts focusing on

developing a quality manufacturing setup in the

pharma sector, involving more technologies to

revolutionize the sector further striking a

balance between pricing and quality.

The event witnessed a participation from

over 150 exhibitors from across the country

including notable industry players such as

Kirloskar, Standard Group of Companies,

Borosil Glass Works, Bry-Air Asia, Rotomark

Innovations, Control Print, Gandhi Automation,

Leistung Engineering, Mack Pharmatech,

Domino Printech, Autocal Solutions, FLIR

Systems, Helios Concrew, Kirloskar

Pneumatics, S.K. Pharma Machinery, NPM

Machinery, Goel Scientific, GMM Pfaudler, ELGI

Equipments, First Source Lab, Apex

Chromatography, Valfit Engineers, Integrated

Cleanroom Technology, Dumra Machines,

Sigma Scientific Glass, among many others.

USFDA OPENS DOOR TO DRUG IMPORT

The import of the drugs would be

limited to the drugs that are off-patent and

have no exclusivity remaining

US Department of Health & Human

Services (HHS) said that the Donald Trump

30

administration is working on ways to

import drugs from other countries. US

President Trump has been vocal about the

administration’s concern over the soaring

novel drug prices and lower competition.

working group would not dilute intellectual

property rights or affect incentives for

innovation. Rather, they would provide a

new avenue for competition to drive down

prices for American patients.

This is positive for Indian pharma

industry as India is having highest number of

USFDA approved drug manufacturing plants

outside the US. If this opportunity comes,

Indian companies are likely to benefit.

CHINA READY TO SLASH INDIAN MEDICINE TARIFFS

In order to overcome the shortcoming and

lower the price of prescription drugs, the Trump

administration is now exploring ways to safely

import certain drugs from foreign countries.

As per HHS Secretary, Alex Azar, USFDA is

forming a working group to examine how to safely

import prescription drugs from other countries in

an event of a dramatic price increase for a drug

produced by one manufacturer and not protected

by patents or exclusivities.

This working group will examine the

potential to promote competition for drugs that

are off-patent or off-exclusivity and produced by

one manufacturer. This stands in contrast to

proposals to import a broader range of drugs,

which raise additional questions about how to

protect American patients.

The working group will consider drugs

unprotected by patents or exclusivities, which

will allow other manufacturers to introduce new

competition. Importation will be limited to cases

where drugs can be imported with adequate

assurances of safety and effectiveness.

Because the drugs being considered for

importation are off-patent and have no exclusivity

remaining, the proposals contemplated by the

India has particularly pressed China

to open up its market for pharmaceuticals.

There is widespread demand in China for

Indian anticancer drugs which are often

one-tenth the cost of the Western drugs

that are available in China

China and India have entered in an

agreement to reduce tariffs and increase imports

of Indian medicines, particularly anti-cancer

drugs, part of moves to broaden its trade relations

amid its on-going spat with the United States.

Both India and China slashed import

tariffs of a range of products starting July 1,

following the fourth round of negotiations

under the Asia Pacific Trade Agreement

(APTA), which also includes Bangladesh,

Laos, South Korea and Sri Lanka.

China said it would reduce tariffs on 8549

items including chemical and agricultural

31

products, while India would do likewise for

3142 products.

India has particularly pressed China to

open up its market for pharmaceuticals,

which was highlighted by Prime Minister

NarendraModi during the April 28 Wuhan

Summit with President Xi.

The Chinese Foreign Ministry said on

Monday that China and India had reached

an agreement on reducing tariffs on Indian

medicines, especially anti-cancer drugs.

There is widespread demand in China for

Indian anticancer drugs which are often

one-tenth the cost of the Western drugs

that are available in China.

Indian drugs, especially cancer curing medicines,

are in big demand in China as they are far

cheaper. About 4.3 million people are diagnosed

with cancer annually in China. In May, China had

lifted tariffs on the import of cancer drugs. India has been demanding the opening of

China's IT and medicine sectors as part of

measures to reduce over USD 51 billion trade

deficit in over USD 84 billion bilateral trade.

Both the sides have stepped up negotiation to

import Indian rice, sugar and pharmaceuticals

after a meeting between Prime Minister

NarendraModi and Chinese President Xi Jinping

during the April 28 Wuhan informal summit.

32