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Prepared by-Saurabh Nigam MBA(pharm.) 1 st sem Roll no.-14PMM504 9/13/2014 Department of Pharmaceutical Management 1

Red tape trials.pptx1

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Page 1: Red tape trials.pptx1

Prepared by-Saurabh Nigam

MBA(pharm.) 1st sem

Roll no.-14PMM504

9/13/2014Department of Pharmaceutical

Management 1

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*FLOW OF PRESENTATION*What is RED TAPE..???Scenario of R & D in India.Guidelines for conducting clinical trials in India.Poor ecosystem of India-:a) Advantages for conducting clinical trials in India.

b) Disadvantages for conducting clinical trials in India.

Expensive but better ecosystem in abroad Drug Price control Order(DPCO) Threat for Indian population-host of tropical

diseases. Current News

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Red tape is an idiom that refers to excessive regulation or rigid conformity to formal rules that is considered redundant or bureaucratic and hinders or prevents action or decision-making. It is usually applied to governments, corporation and other large organizations.

One definition is the "collection or sequence of forms and procedures required to gain bureaucratic approval for something, especially when oppressively complex and time-consuming".Another definition is the "bureaucratic practice of hair splitting or foot dragging, blamed by its practitioners on the system that forces them to follow prescribed procedures to the letter".

Red tape generally includes filling out paperwork, obtaining licenses, having multiple people or committees approve a decision and various low-level rules that make conducting one's affairs slower, more difficult, or both. Red tape can also include "filing and certification requirements, reporting, investigation, inspection and enforcement practices, and procedures".

9/13/2014 Source : Business Standard 3

What is Red Tape..??

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Bundle of US pension documents from 1906 bound in red tape

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Clinical trials is a practice of testing drugs upon people but due to arduous rules and regulations

i.e. red tape imposed by Indian government researchers and scientist was unable to perform his

work in the manner in which they want to do.

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Red tape w.r.t clinical trials..??

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How red tape changed the scenario of R&D in India..??

• Ten years ago, India wanted the hub for drug research.

• Some scientists said they could discover and develop a new molecule for less than $100 million - a tenth of what it cost abroad then.

• According to a report by McKinsey, the global clinical trial outsourcing opportunity in India in the pharmaceutical industry is estimated to be around $2 billion by 2010, and there will be the demand for more than 10,000 investigators trained in good clinical practice (GCP).

9/13/2014 Source : Business Standard 6

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Indian loses chance to be research hub as domestic drug companies move R&D overseas

Piramal Enterprises, the Piramal group's flagship company operating primarily in the healthcare sector, has decided to close its Mumbai drug research and development (R&D) unit, its largest in the country.

9/13/2014 Source : Business Standard 7

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• .MUMBAI: Pharma major LUPIN said it is in the process of setting up two new R&D centres in the US, focusing on research in inhalation and on complex formulations.

"In keeping with our global strategy of building a highly differentiated generic and speciality business, the company is in the process to setting up two dedicated Centres of Excellence for research in inhalation and complex injectables in Florida and Maryland in the US," Lupin chairman Desh Bandhu Gupta said in its annual report.

9/13/2014 Source : Business Standard 8

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• Sun Pharmaceutical Industries Ltd (SUN.NS), India's third-largest generic drugmaker by sales, said that it had acquired U.S.-based Pharmalucence Inc, which has sterile injectable capacity and research capabilities.

• Cipla has said that it will invest about Rs 1,000 crore in Britain to develop drugs for respiratory- and oncology-related diseases. CIPLA Ltd, in collaboration with the UK government, has expressed its intention to make investments of up to GBP 100 million (about Rs 1028 crore) in its UK subsidiary over the next few years.

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Source : IGMPI|Institute of Good Manufacturing Practices India

10

•1996 : ICH Guidelines•2000 : ICMR Guidelines •2001 : Indian GCP Guidelines•2003 : Revision of BE Guideline•2003 : Revision of Schedule Y

Guidelines for conducting clinical trials in India

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9/13/2014 Source : New York Daily News 11

How guidelines were not followed and various giants were penalized

1) Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once led U.S. regulators to bar imports of the Indian company's medicines.

2) Generic drugmaker Ranbaxy Laboratories Ltd(RANB.NS) pleaded guilty on Monday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department of Justice

Forty-milligram tablets of the drug Lipitor photographed in Glen Rock, N.J., Tuesday, Nov.

15, 2005. Lipitor (atorvastatin calcium) is a prescription drug for lowering cholesterol

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1. Just two years after emerging from a financial crisis caused by derivative bets gone awry, Mumbai-based drug maker Wockhardt Ltd is confronting more trouble—this time in the form of penal action by the US regulator.

2. .The US Food and Drug Administration (FDA), which last year banned generic drug imports from Wockhardt’s plants at Waluj and Chikalthana in Maharashtra citing flawed manufacturing processes, on 27 May voiced

concern about production quality at the company’s US unit.

FDA scrutiny of US unit looms over Wockhardt

Wockhardt shares have dropped around 70% since the FDA action against its Waluj factory in

May 2013, followed by the ban on the Chikalthana plant in September

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1.

1.Sun Pharma recalls 500,000 bottles of Cephalexin capsules from US.

2. Dr.Reddy recalls 13000 bottles of Anti-Hypertensive drugs from US market.

3. Anti-allergic drugs recalled by Zydus Cadilla from US market.

4. USFDA imposes ban on products made at Sun Pharmas Gujarat plant.

5. Ranbaxy recalls generic LIPITOR from US market.

Companies which not followed the Good Manufacturing Practices In India

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Sophisticated productsAlternative medicineNew public health threatsInternational commerceConsumer awarenessInformation technologyRegulatory activismGlobal ethicsMedia pressure

Challenges for Pharmaceutical Industries

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Critical path for clinical trials

PLANNING

PROTOCOL • CRF

REGULATORY AND ETHICALAPPROVAL

TRIAL DOCUMENTS.MATERIALS

SELECT INVESTIGATORS

INITIAL VISITS

SITE ASSESSMENTS

*END*START

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Why India…??

India has a huge population base of more than 1 billion (Indians represent about 15% of the global population)

This population is genetically, culturally and socio-economically diverse

Asians have been seen to react differently to drugs as compared to their Caucasian counterparts

India has the largest pool of patients (e.g. the highest number of cancer and diabetes patients are found in India)

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Why India…??

The patient population in India is mostly treatment naïve.

Patient: doctor ratio is high. There is no dearth of professionals trained in

the field of medicine. India has a large pool of highly qualified and

dedicated scientists and clinical research professionals.

It is from tropical infections to degenerative diseases home to a wide variety of diseases ranging

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Treatment naïve population

High patient enrolment rate

Broad spectrum of diseases

A more rapid approval of trials

Availability of human resources

Technical skills

Differing ethnic responses to drugs

cost advantages

Advantages in India

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Ongoing Clinical Trials on Various Therapeutic Areas in India

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NUMBER OF CLINICAL TRIALS IN INDIA

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9/13/2014 24Source : "India's Emergence as a Global R&D

Center

COST ADVANTAGES

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15% stated that they entered the trial because they were looking for a cur

13% were looking for “observed benefits”.

15% were looking for a better treatment.

16% were looking for higher quality care.

10% were looking for free medication and medical care.

15% said the doctor advised them to enter the trial.

5% said they entered the trial to receive money for participation.

11% said they entered the trial to help advance scientific knowledge.

MOTIVATIONS TO PARTICIPATE IN A CLINICAL TRIAL

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Disadvantages of conducting clinical trials in India

The major disadvantage is the lengthy approval timeline of drug products.International phase 1 clinical trials with new chemical entities developed in a foreign country(First –in-human trial )are not allowed in India.The committee which regulates these things overcomes with various hurdles such as the fact that expert committee members must be available to meet at a joint forum.The decision usually not taken during a single session,therefore multiple sessions are required.

Source : The Clinical Trials Guru

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Furthermore , queries raised during such meetings takes a significant amount of time to be drafted and circulated to the applicants response.Clinical trials applications submitted to the DCGI where DCGI office does not have the competency to review such protocols.For this outside agencies such as the ICMR, the BARC , the DBT , the AERB are hired for their review and opinion.As we can see , the approval time for these trials is no walk in the park in INDIA.

Source : The Clinical Trials Guru

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EXPENSIVE BUT

BETTER ECOSYSTEM IN

ABROAD

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Less competition

Easy to introduce new products in market

Financial flexibility

Availability of qualified persons

Less complexity in product development

Transparency in the government

Advantages of clinical trials in abroad

Source : US pipeline project-EMPOWERING COMMUNITY...ACCELERATING THERAPIES

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A favorable ecosystem that allows the conduct of global trials , duty free imports of drugs intended for use in trials bioequivalence studies for export of data.High quality of research professionals in the medical and scientific fields.Recruitment time can be halved , a significant advantage to sponsors seeking hundreds , and sometimes thousands of clinical trials participants.India’s billion plus population offers tremendous genetic diversity and a large patient population that has never received drug treatment.

Source : US pipeline project-EMPOWERING COMMUNITY...ACCELERATING THERAPIES

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Threat for Indian Population

India is a host of many tropical diseases.Each state of India has different disease. Researchers should work in the field of these diseases.RED TAPE is a threat for Indian population as many pharmaceutical industry start moving towards out of India. Government should be transparent so that this problem can be resolved. It is mandatory for industries to strictly follows the regulations imposed by DPCO.

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Changing Disease PatternsCardiovascular diseasesDegenerative neurological

diseasesDiabetes CancerPsychiatric illnesses Gastro Intestinal DisordersInfectious Diseases Tropical diseases

Patient Population 8 million Epileptics

40 million Asthmatics

~34 million Diabetics

8-10 million HIV +ve

3 million Cancer patients

> 2 million Cardiac deaths

1.5 million Alzheimer patients

1 million PD patients

15% Hypertensive

1% Schizophrenia patients

Diseases and Patients

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