Overview

Our research on Drug Regulatory Reforms in India seeks to address the specific regulatory issues in the Indian pharmaceutical sector. An initial scoping workshop was conducted to identify the problem areas and research questions in this sector.

As a part of ICRIER’s Health Policy Initiative, full day workshop was conducted on drug regulatory reforms in India on 31st March 2014 in New Delhi. The goal of this workshop was to discuss and deliberate various issues of concern in the context of drug regulation in India, which would be taken up to develop ICRIER’s research agenda in this field. It was attended by distinguished experts from the government, international organizations, academia, industry as well as the civil society. Discussions focused on following themes: drug safety, Good Manufacturing Practices (GMP), Post-Marketing Surveillance (PMS), clinical trials and new drug approvals and other relevant issues.

The inaugural address was delivered by Mr Arun Maira, Member, Planning Commission, Government of India. Notable participants included Dr B R Jagashetty, Former Drug Controller of Karnataka; Mr Sudhanshu Pandey, Joint Secretary, Ministry of Commerce and Industry, Government of India; Dr A Ramkishan, Deputy Drug Controller, Ministry of Health & Family Welfare, Government of India; Mr Ratnesh Sahay, Advisor, Competition Commission of India; Dr Genevieve Begkoyian, Chief of Health, UNICEF India; Dr Shubhashis Gangopadhyay, Research Director, India Development Foundation; Dr Aditya Bhattacharjea, Professor and Head of Department, Department of Economics, Delhi School of Economics; Dr Amir Ullah Khan, President, Glocal University; Mr Richard F Kingham, Partner, Covington and Burling (Washington D.C.); Ms Susan C Winckler, President, Food and Drug Law Institute (Washington D.C.); Dr Bobby John, President, Global Health Advocates, among others.

This workshop resulted in the emergence of six themes to be covered over a period of three years.Each of the papers will be based on detailed review of the Indian system along with an exploration of the international best practices.The following are the six themes of the project:

YEAR 1

  • Drug Quality and Safety – While globally there is much talk about the poor quality of drugs produced by the Indian pharmaceutical industry, it only results in creating more confusion about the precise extent of the problem. This study attempts to address very specific quality and safety issues that are immediately relevant in the Indian context and thus focuses explicitly on issues in manufacturing and distribution of drugs. The ultimate goal is to examine these problems down to their roots and also to learn from the way these problems have been addressed elsewhere.

Researchers assigned: Maulik Chokshi (Team Leader), Vasudha Wattal, Rahul Mongia

  • Administrative Structure and Functions– The role of government in ensuring safety, efficacy and quality of pharmaceutical products is very crucial in all healthcare systems. In India, both the central and state governments are the primary regulators in the sector. While the central government regulates the new drugs approval and imports through Central Drugs Standard Control Organisation, the state governments are responsible to regulate the manufacturing, sale and distribution of pharmaceutical products through State Drug Control Authorities. However, the prevailing drug regulatory structure has been criticized especially due to the presence of spurious drugs in the country, which led to the formation of Mashelkar Committee in 2003. The Committees found that the problems in the drug regulatory system in India is mainly due to the weak drug control infrastructure at the Central and State level and thereby recommended the need for centralized licensing of drugs. In this context, our study is to review the administrative structure and functions of the drug regulatory authorities in India with the aim of identifying critical challenges and suggests a possible agenda of reform. Specifically, the study focused on three aspects of regulation, i.e., marketing authorization, manufacturing and sale of pharmaceuticals.

Researchers assigned: Nupur Chowdhury (Team Leader), Beena Saraswathy, Arpita Patnaik

ONGOING RESEARCH (2015-16)

  • Harmonization of drug registration procedures – An impact assessment for India– Divergences in national regulatory frameworks have the potential to impose major transaction costs for both regulators and industry, and subsequently pose a challenge for public health. Such concern has provided impetus to international cooperation and harmonization of regulatory standards through initiatives at regional and international levels. India is not part of any ongoing harmonization initiative. Given that Indian pharmaceutical industry is well-integrated into the global value-chain, and with rapidly changing disease profile in the country needing newer and better treatment options, Indian policymakers need to address the issue of harmonization on a priority basis. This paper tries to explore some of the options for the consideration of Indian policymakers.
  • Challenges and prospects for clinical trials in India– Clinical trials are critical for drug development process as they help establish safety and efficacy of new drugs. India has had favorable conditions for conducting clinical research and drug development – a large and diverse patient pool (trial subjects), qualified scientists (investigators), medical institutions (sites), etc. Yet, an unfavorable ecosystem and public perception have undermined their potential – only 19 trials were approved in 2013, a drop of roughly 93 percent from 2012 (262 trials), and a fraction of its peak of 500 in 2010. This paper will look at three key aspects of CTs – ethical, procedural and uncertainty embodied in the current regulations – and develop actionable recommendations for policy reform in the Indian context.