India Looks to Boost Quality, Regulation and Reputation of Pharmaceuticals
India's Drugs Consultative Committee (DCC) has released a report of its November 2013 meeting, with recommendations under the 12th Five-Year Plan for strengthening the country's drug regulatory infrastructure at both the central government and state levels.
Noting that India is the third largest producer of drugs by volume (with a value of $28 billion) and exports about half of its production to more than 200 countries, the emphasis of the meeting was on enhancing the country's international reputation and ensuring that its drug industry is not compromised by reports of substandard products.
Joint Secretary of India's Ministry of Commerce & Industry Shri Sudhanshu Pandey claimed at the meeting that drug imports from India - particularly generics - are being targeted by a number of countries in an attempt to protect their domestic pharmaceutical industries, and stressed that it is India's responsibility to ensure the reputation of its pharma industry on the international market.
To this end, the reports recommends enhancing the regulatory infrastructure by increasing manpower, stepping up training of regulatory officials, enhancing testing facilities, requiring states to upgrade their regulatory systems and requiring CDSCO to inspect at least one clinical trial site every month.
The Ministry of Health and Family Welfare's Shri R. K. Jain also urged representatives from state regulatory agencies as well as the CDSCO to be present during the inspection of a local Indian manufacturing unit or a clinical trial site by agencies of the European Union and the US Food and Drug Administration (FDA).