The Drugs and Cosmetic Act has Schedule M, which has been revised recently, and which spells out Good Manufacturing Practices (GMP). The idea behind revision of the GMP is to bring it on par with World Health Organisation’s (WHO) standards.
India wants to implement these standards in a phased manner. Of course, those companies which export drugs to other countries such as the US have to be compulsorily WHO-GMP compliant. However, so far, domestic companies did not comply with these, and out of 10500 drug manufacturing units, only a fifth were WHO-GMP compliant.
The government has set now a mandatory deadline for its implementation. Those companies with a turnover of Rs.250 crore will have to comply within next six months and those with a turnover of less than RS.250 crore will have to do so within a year.
India is known as a pharmacy to the world. However, there are issues about the drug quality and safety standards. The US FDA raises Official Action Indications for Indian drugs. There are at times import alerts and the concerned drug makers are banned from supplying to the US. There are instanced of drug safety failure in domestic market too.
Mere making the compliance will address only part of the problem. Specific changes are necessary in manufacturing processes. There should be full-fledged quality control system including product quality review. There should be stability tests and validation of equipment. Eye preparations and injections must be sterile. Testing laboratories should be inspected.
There is fragmented structure of drug regulation. Under Central Drugs Control Organisation (CDSCO), there are 37 nodal agencies across India. There is regulatory chaos and regulatory silos. The drug regulation is federal. Ease of business is promoted at the cost quality. There is a demand for centralised regulation and licensing. The enforcement gaps must be fixed.
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