DCGI clips state wings on WHO certificate issue

The certificate is a stamp of compliance with the WHO standards which all member states have been urged by the global organisation to adopt and works as a passport for mutual recognition of inspection standards regarding manufacture of drugs.

The DCGI has centralised the process on the pretext that the certificates issued by states in many cases do not conform with the norms of WHO certification scheme and in some cases even the prescribed formats are not adhered to. The DCGI is also of the view that the certificate format has been interpreted variedly by different state drug controllers, leading to confusion among the regulatory authorities of importing countries over the nature of WHO COPP originating from India.

The DCGI officials also point out that WHO guidelines recommend that the certificate, a stamp of approval for the final dosage of pharma product and the model certificate of good manufacturing practices for medicinal products (for manufacturing plants producing these drugs), should be issued by the national regulatory authority of the producing country. In a letter to DCGI, the WHO has objected to the state licensing authorities giving out certificates bearing the title of ?WHO GMP Certificate?.

Expectedly, the decision has ruffled feathers among state drug controllers, some of which have been strongly advocating status quo. Some of them feel the government should have trained and prescribed standard format to state offices and given them a chance in the form of a period of transition before arriving at such a decision. However, a few drug controllers such as that of Maharashtra and Delhi are supporting the decision on the grounds that the area of international commerce is the primary responsibility of the Centre.

According to the Centre, the arrangement of delegating the duty to state governments was in any way a temporary arrangement as the office of DCGI was understaffed. With the strength of drug inspectors under DCGI now expected to touch 200 by the end of 2010, the office would have adequate manpower to execute all its duties.

The decision has also not gone down well with smaller and medium drug enterprises, which are expressing apprehensions that such a move would lead to further delays in certificate deliveries. ?We are currently considering whether meeting DCGI and appealing for a revision of the decision would help,? said an industry member.

However, large pharma companies are unlikely to be greatly affected by the decision as a major chunk of their exports is directed to the US and other matured markets which have their own regulatory approval systems and do not require the furnishing of COPP to allow trading.