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.
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).
“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.
In the recent surveys by CDSCO around 4.5 per cent of the drugs in the Indian market were found to be of substandard quality.
According to a recent paper by the Associated Chambers of Commerce of India (ASSOCHAM), counterfeit and substandard drugs are a growing problem and estimates indicate that such drugs constitute nearly one third of all drugs sold in NCR.
The fake drugs market is likely to cross US$ 10-billion mark by 2017, according to a report by the industry body. The concentration of fake drugs manufacturers can largely be found in Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and Punjab etc, an ASSOCHAM paper stated.
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