Centre Directs Pharmaceutical Companies to Self Govern on Quality | Len Mistretta

All pharmaceutical companies will have to submit a self assessment and quality rating based on global standards. It is aimed at creating more transparency and increasing the responsibility of the pharmaceutical companies. The Central government has made it mandatory for all pharmaceutical companies to submit a self assessment and quality rating based on global standards in a bid to curb the sale of spurious and substandard drugs.

DRUGS AND COSMETICS ACT REVAMPED

In a major revamp of Drugs and Cosmetics Act, 1940, the Central Drugs Standard Control Organization (CDSCO) under Union Health Ministry has prepared a detailed checklist for all manufacturing facilities. They will now have to comply with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as specified under Drugs and Cosmetics Rules. The checklist prepared by CDSCO also includes World Health Organisation (WHO) GMP and Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards. "The tool has been devised with a view to ensure that each pharmaceutical manufacturing unit also carries out self-assessment," said Dr G N Singh, Drugs Controller General (India).

AIMS AT TRANSPARENCY AND INCREASED RESPONSIBILITY OF PHARMA COMPANIES 

We aim to end license raj in the country. We want to device a transparent system in which there are stricter rules and punishment. Pharmaceutical companies would be more responsible with this system and there will be an improvement in the quality of drugs," said Dr Singh.
According to government's own surveys, there are a considerable number of substandard drugs thriving in the country. Based on the samples taken by CDSCO during 2011-12 to 2014-15 (up to September, 2014), 3.33 per cent samples were found to be not of standard quality.  Read More....