The Indian Council for Research on International Economic Relations (ICRIER) is now focusing on the drug regulatory reforms in India as the country is at the cusp of a pharmaceutical and medical device regulation reformation phase.

The Council went on to highlight two key focus areas needed to transform the drug regulatory landscape. One was to view the administrative structure and functions of drug regulatory authorities in India and the other was to have an in-depth comprehension of the current drug quality and safety issues in India.

According to Dr Nupur Chowdhury, consultant, ICRIER, the key objective of drug regulation is to ensure patients access to safe, good quality and efficacious drugs. A drug regulatory administration is needed to facilitate the achievement of this objective. For this, it is critical to put in place a dynamic and responsive regulation.

For the conception of a regulatory system, a primary need is to ensure stakeholders are sensitive to regulations. We will need to map the functioning of Central Drugs Standard Control Organisation (CDSCO) and State Drug Regulatory Authorities (SDRAs) to examine the nature and scale of challenges confronting the regulatory authorities, said Dr. Choudhury who was deliberating at the ICRIER seminar  held recently at New Delhi.

Further it is vital to explore lessons drawn from experiences from global jurisdictions like the USFDA and EMA to ensure that regulations help evolve a set of actionable policy recommendations which are current to cover the new developments in drug research, he added.

Deliberating on final dissemination seminar on 'Drug Regulatory Reforms in India', Dr. Choudhury focused on the ‘Administrative Structure and Functions of Drug Regulatory Authorities’ in the country. The recent reform efforts began with the  Mashelkar Committee Report 2003 which was quite comprehensive covering recommendations on spurious drugs and  indicating a ratio of personnel including inspectors to pharma plants in the regulatory departments. Another transformation on the regulatory landscape in India came in with the Ranjit Roy Chaudhary Committee Report 2013 which mandated stringent norms for  clinical trials and new drug approvals. The recent Drugs & Cosmetics Amendment Bill 2015 called for central licensing of 17 categories of drugs, he said.

Recommending the need for major policy changes, Dr. Chowdhury said there was need to expand the legislative mandate of Drug Consultative Committee (DCC), ensure public outreach and transparency by building public confidence besides strengthen the risk-based inspections.

Discussing on the drug quality safety issues in the country was Maulik Chokshi, consultant, ICRIER who said that the need of the hour was to undertake drug sampling not just from production plants but also pharmacy outlets in rural areas to  make certain efficacy of medicines and wellbeing of the patients.

Dr. BR Jagashetty, former national advisor, (drugs control) to ministry of health & family welfare, and former Karnataka drugs controller who was a participant at the seminar insisted on the creation of a cadre ‘Indian Drug Administrative Service (IDAS) on similar lines that of the Indian Administrative Service (IAS) to ensure uniformity in the functioning of the regulatory departments at all states.