DCGIs plan to centralise WHO certification hits legal hurdles

Written by Soma Das | New Delhi | Updated: Oct 30 2009, 04:52am hrs
The governments attempt to centralise the issuance of WHO certificate for pharma export have hit multiple hurdles with courts issuing four stay orders on the Drug Controller General of Indias (DCGI) move within a span of 10 days. Three of the stay orders have been granted by the Madras High Court and one by the Karnataka High Court while hearing cases of state drug inspectors and various pharma exporters. The drug exporters claim that such a move would paralyse the system.

How would DCGI with its current strength of 20 central drug inspectors manage to grant new certificates and renew them to over 5,000 pharma units spread across the country, at a time when the state licensing authority in Tamil Nadu with a manpower of 60 is finding it difficult to issue certificates to the 800 manufacturing units in the state that garner over Rs 4,000 crore as export revenue asked drug exporters. Additionally, drug exporters have directly challenged the DCGIs power to implement such a move, which according to them is not the national regulatory authority under the Drug and Cosmetics Act (DCA).

In the latest plea, exporters argued that under the current law of the country, DCGI is just an approving authority and does not have the power to grant licences to manufacture drugs. It is responsible for approval of new drugs, clinical trials in the country, laying down standards for the drugs, control over the quality of the imported drugs, coordination activities of the state drug controllers providing expert advice with a view to bring about the uniformity in the enforcement of the DCA, exporters argued. So, the WHO guidelines that ask for a certificate from a national drug authority or a competent authority cannot be construed to mean the DCGI. Exporters allege that DCGI has overstepped its jurisdiction through the Act.

However, DCGI maintains that it is precisely at the request of the WHO that the regulator took such a step. Officials point out that when WHO refers to a competent authority, it doesnt say authority(ies), which directly warns against creating multiplicity of agencies to grant the certificate.

State drug controllers were issuing the WHO GMP Certificate until the end of September, but the international agency apparently objected to this in a letter to DCGI. A DCGI official said that WHO mandates that only a national regulatory authority approve the final dosage of pharma products and issue the certificate of good practices to manufacturing plants. The DCGI stated that in many instances, certificates issued by states do not conform to WHO norms and, in some cases, even to prescribed formats. Many states have interpreted the format differently, leading to confusion among the regulatory authorities of importing countries over the WHO certificates originating from India.

In a letter to DCGI, the WHO has also objected to the state licensing authorities giving out certificates bearing the title of WHO GMP Certificate. Based on this, the regulator decided to centralise the issuance of the certificate from October 1.

According to the Centre, delegating the duty to state governments was a stop-gap arrangement, as the office of the DCGI was understaffed. With the strength of drug inspectors under DCGI now expected to touch 200 by the end of 2010, it would have adequate manpower to execute all its duties. In the latest stay order, the Madras High Court has allowed the state licensing authorities to continue the issuance of certificate for next eight weeks.

This WHO certificate is insisted upon by governments of several countries in Latin America, Africa, South East Asia and East Europe for drug exports to these destinations.

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.