Visit

of

Dr. G. N. Singh, DCG(I)

to

Ahmedabad, from 11-12th

January, 2015

Central Drugs Standard Control Organization,

Zonal Office, Air Cargo Complex, Ahmedabad,

Gujarat.

The Drugs Controller General of (India) visited Ahmedabad, Gujarat from 11th & 12th

January, 2015 in response to the invitation received from Government of Gujarat as a

Special Invitee to attend a seminar on Health for All – Leveraging Technology,

Innovation and Enablers held during 7th Vibrant Gujarat Global Summit at Gandhinagar,

Gujarat.

Schedule of the visit:

Date Time Events

11th January,2015 (Day 1)

11:00 AM to 12.30 PM Meeting with Medical Devices and diagnostic Industry Representatives

01:30 AM to 03:00 PM Visit to Mahatma Mandir to attend inauguration of 7th Vibrant Gujarat Global Summit at Gandhinagar, Gujarat.

03:00 PM to 05.00 PM Meeting with CRO Representatives

05:45 PM to 06:30 PM Meeting with Deputy Foreign Minister of Poland

07:00 PM to 09:00 PM Meeting with members of IDMA, Ahmedabad Branch at Regenta Hotel, Ashram Road, Ahmedabad.

12th January,2015 (Day 2)

09:00 AM to 11:00 AM Seminar on health for all – Leveraging Technology, Innovation and Enablers held during 7th Vibrant Gujarat Global Summit at Gandhinagar, Gujarat.

11:30 PM to 01:00 PM Visit to Gujarat Forensic Science University, Gandhinagar.

03:00 PM to 04:00 PM Meeting with CDSCO Staff at CDSCO Zonal office, Ahmedabad.

04:00 PM to 04:30 PM Meeting with Gujarat State Export Council (GSEC) Chairman Mr. Rakesh Shah

04:30 PM to 05:30 PM Meeting with representatives from Ahmedabad Custom House Agents Association (ACHAA)

07:30 PM to 09:30 PM Meeting with IPA Members

(Day 1) :

Meeting with Medical Devices and Diagnostic Industry Representatives: The DCG(I) arrived Ahmedabad on 11th January, 2015 and joined the Medical Device

Manufacturer’s meeting at J.B. Auditorium, Ahmedabad Management Association

(AMA), Ahmedabad. The DCG(I) had interactive meeting with the stake holders of the

medical Device industry. After formal introduction of the members, DCG(I) has briefed

gathering about vision, mission, and values of CDSCO. He has stated that medical

device industry has great potential for growth and plays important role in healthcare

industry. CDSCO is in the process of streamlining regulations of medical devices for the

growth of the industry. He has informed that marketing authorization granted by the

Indian regulators will be accepted by the other countries provided products are

manufactured as per prescribed standards.

Industry representatives gave suggestions on various issues of the industry like reuse of

medical of devices by the hospitals, harmonization of regulation, timelines for approval,

three tier system for approval of new devices, post approval changes, harmonization of

regulatory procedures available on website of CDSCO and other states, new testing lab

for medical devices, regulation of pathological laboratories and proposed amendments

to Drugs & Cosmetic Act and Rules.

Industry also expressed their concern about requirement of approval of USFDA/ CE

certification for the procurement of devices for local hospital/ government supply.

DCG(I) requested all the members to submit detailed note on above issues to the

CDSCO at the earliest such that government can initiate necessary action on these

issues on priority.

The DCG(I) encouraged all the stake holder and individual to submit comments on draft

Drugs and Cosmetics Amendment Bill 2015 available on website of CDSCO and

Ministry of Health & Family welfare.

Industry representatives expressed their sincere gratitude and thanks to the DCG(I) for

first time having meeting with the industry representatives and also requested DCG(I) to

have such meetings at the regular intervals, at least once in six months.

The list of representatives of medical device industry participated in the meeting is

enclosed at annexure- I.

Visit to Mahatma Mandir to attend inauguration of 7th Vibrant Gujarat Global

Summit at Gandhinagar, Gujarat.

DCG(I) attended the inauguration of 7th Vibrant Gujarat Global Summit. Dr. H. G. Khosia

Commisioner FDCA Gandhinagar met the DCG(I) at the inaugural venue.

Meeting with CRO Representatives:

The representative from the Clinical Research Organization (CRO) was held at Hotel

Hyatt, Ahmedabad. The list of participants from CRO is enclosed at Annexure-II.

The DCG(I) has conveyed to the members that there should be uniform pay for

participants of BA/BE study. He also stated that it is advisable to have Online Volunteer

Information System (OVIS) in all CROs and shall be inter connected (National Grid ) to

prevent cross participation of subjects in BA/BE studies.

The stake holder of CRO discussed various issues with the DCG(I) like predictability

and consistency in the approval process, necessity for review of BA/BE protocols by the

subject expert committee, validity of certificate from 01 year to 03 year, updating of new

drug information on CDSCO website, regulation of orphan drugs, OTC drugs, etc.

They also requested DCG(I) to address issue of import of biological sample for analysis

in consultation of DG ICMR.

Meeting with Deputy Foreign Minister of Poland

As per the schedule the Deputy Director of Department of Economic Cooperation,

Ministry of Foreign Affairs, Poland and the Undersecretary of State, Ministry of Foreign

Affairs, Poland had meeting with the Drugs Controller General of India at Novotel Hotel,

Ahmedabad.

Poland has shown interest to have MOU with Indian regulatory authority for exchange of

information, training, participation in seminar/ conferences, study visits, joint research

program etc.

DCG(I) has explained to the Poland delegation about Indian Drugs Regulatory system,

current status of pharmaceutical industry, measures taken for strengthening of

regulation and skill development of regulators. He also informed that proposals of MOU

shall be forwarded through proper channel (Ministry of External Affairs and Ministry of

Health).

Delegation has formally invited DCG(I) to the Poland.

Meeting with members of IDMA, Ahmedabad Branch at Regenta Hotel, Ashram

Road, and Ahmedabad.

Interactive panel session was held with representative of IDMA at Hotel Regenta,

Ashram Ahmedabad. Shri Sudhanshu Pandey Joint Secretary, Ministry of Commerce,

(Foreign Trade), Dr. G. N. Singh, DCG(I), Dr. S. Eswara Reddy, JDC(I), Dr. H.G.

Khosia, Commissioner, FDCA, Gujarat, and Shri P.V. Appaji, DG, Pharmexil were also

present.

DCG(I) requested all the members to send comment on draft Drugs & Cosmetics

Amendment Bill 2015 and Drugs & Cosmetics Rules. He also informed that CDSCO

port offices has started functioning on 24x7 for clearances of import and export

consignment starting from 01st January, 2015.

Members of IDMA expressed concerns over FDC, delay in approval of clinical trials, non

uniformity in implementation of “guidelines for taking action on samples of drugs

declared spurious or not of standard quality in the light of enhanced penalties under the

drugs and cosmetics (Amendment) Act 2008” issued by the CDSCO, notification of

Mundra port, notification of Bank of Baroda Ahmedabad branch for payment for fees

etc.

The list of participant in interactive panel session is enclosed annexure-III.

(Day 2) :

7th Vibrant Gujarat Global Summit at Gandhinagar

DCG(I) has participated Seminar on Health for All – Leveraging Technology, Innovation

and Enablers held on 12th January, 2015 during 7th Vibrant Gujarat Global Summit at

Mahatma Mandir, Gandhinagar, Gujarat. Honorable Minister of Health and Family

Welfare, Govt of India was the chief guest of the seminar. Shri Luv Verma Secretary

Ministry of Health, Govt of India was also present.

Visit to Gujarat Forensic Science University, Gandhinagar.

DCG(I) met Dr. J. M. Vyas, Director General of Gujarat Forensic Science University

(GFSU) and Prof. Y. K. Agrawal, Director Institute of Research & Development at

University campus, Gandhinagar. It is decided to utilize facilities of GFSU for training of

Indian regulators on various modules in association with IIM-A, NIPER, Nirma University

etc. The expenditure towards training programs will be born from the IPC budget.

Deputy Drugs Controller of Ahmedabad CDSCO zonal office will be nodal officer for the

training program.

Meeting with CDSCO Staff at CDSCO Zonal office, Ahmedabad.

The Drugs Controller GeneraI India has visited the CDSCO zonal office at Air cargo

complex, Ahmedabad to review functioning of zonal office. JDC(I) has made a

presentation to the DCG(I) on current working, staff strength, achievement and current

issues of the office etc.

The major achievement of the zonal office during the year 2014 are as below :

• Installed Compactor for Document Archival

• Issuance of various NOCs within 24 hrs

• 04 additional contractual staff recruited

• Office vehicle engaged

• Fund granted for ISO 9001:2008 certification

• Two new telephone lines installed

• Purchased Reference books

• Installed CCTV/Biometric attendance system

• Strengthen infrastructure facilities by providing computers, furniture.

• Installed EPABX for internal communication

• Implemented fast file clearance system

• Disposed old files/ applications

• No Single Complaint

• External audit by Dr. Moon, Vigilance Officer with ZERO Non-Compliances

Further following issues of the zonal office have been brought to the notice of DCG(I)

• Independent budgetary / Administrative activities

• Promotion of Mr. V. M. Sethe, Sr. Technical Assistant and Mr. Jigar Patel

Technical Assistant

• Training to staff of Port office

• Training on Administrative matters

• Increase in Salary of Contractual Staff

• Late receipt of test report from laboratory for the drugs/cosmetics sent for test &

analysis

The DCG(I) has kindly agreed to do needful for the above issues.

The DCG(I) had meeting with all the staff member of CDSCO, Zonal office, Ahmedabad

and shared the various ongoing development in the regulatory system and future

proposal. The DCG(I) motivated the entire staff for adhering the values, mission and

vision of the department.

The DCG(I) appreciated the head of the office and his team for the above achievements

made in zonal office of Ahmedabad .

Meeting with Gujarat State Export Council (GSEC) Chairman Mr. Rakesh Shah

Mr. Rakesh Shah, chairman of Gujarat State Export Council met the DCG(I) at zonal

office of Ahmedabad. The DCG(I) discussed the various issues like future expansion

planning regarding set up of mini laboratory at port office etc.

Meeting with representatives from Ahmedabad Custom House Agents

Association (ACHAA)

Meeting with ACHAA representative was held at zonal office. The list of CHA

representative participated in the meeting is enclosed at Annexure-IV. The DCG(I)

briefed the representatives on recent initiative taken by the CDSCO to clear import &

export consignments on 24x7 basis effective from 1st January, 2015.

The CHA representatives appreciated the initiative taken by the head of the zonal office

to streamline the clearance of the shipment bills / bill of entries. Further CHA

representatives requested for followings:

1. Online submission of shipping bills / bill of entries.

2. Notification of Mundra port for import and export of drugs.

It is informed by the DCG(I) that above proposal are already under active consideration

of CDSCO.

Meeting with IPA Members

DCG(I) had meeting with members of IPA. IPA members made a request to examine

the requirement of NOC from the DCG(I) for grant of test license in form 29 for new

drugs including vaccines. They also suggested delegation of other activities from the

head quarters to the zonal offices for speedy disposal, for example NOC for conducting

BA/BE study. They expressed concern over delay in clinical trial approvals due to three

tier system.

DCG(I) informed to the members that he will examine the above issues.

All the associations appreciated the efforts of DCG(I) for his voluntary proposal to meet

association representatives to discuss / share their issues and also to have one to one

interaction with the DCG(I). This type of interactive sessions will help for better

communication with the stake holders to share recent initiative taken by the CDSCO

and also expectation of the regulators on various matters. All association also made a

request to DCG(I) to conduct such type of interactive sessions at least once in six

months.