The central government?s move to centralise WHO certification of pharmaceutical products for export has hit a roadblock, with the Madras High Court staying an order of the drug controller-general of India (DCGI) while hearing a plea by the Tamil Nadu State Drug Inspectors? Association.
The stay, issued on Tuesday, could prolong the uncertainty about who has the right to certify drug exports, which account for Rs 35,000 crore of the overall Rs 85,000-crore pharmaceutical industry. Small & medium enterprises in the sector have, however, welcomed the court?s move, saying the DCGI does not have requisite staff to issue approvals on a national scale.
Centralising certification at a federal level is a WHO recommendation. Except for the US and Western Europe, which have their own systems, such certification is insisted upon by all countries that import drugs.
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. Confirming the development, a DCGI official said WHO had mandated that only a national regulatory authority approve the final dosage of pharma products and issue the certificate of good practices to manufacturing plants.
But many state drug controllers objected to such centralisation and state health secretaries wrote to the health ministry to take steps to abort DCGI?s move. The regulators feel the Centre should have trained and made available a prescribed standard format to the state offices and given them a period of transition before arriving at such a decision. Only drug controllers in some states such as Maharashtra and Delhi supported the decision on the grounds that international commerce falls in the domain of the Centre.
Small & medium drug enterprises claim the centralisation would further delay the processing of certificates, thereby adversely affecting their exports. These companies took up the issue with DCGI, the health ministry and department of pharma, urging them to withdraw the move.
?The stay order comes as a temporary relief. The (DCGI) move reversed a 10-15-year-old system, which has been running without any major hiccups. While we are not against the move per se, what we are suggesting is that the transition should be gradual and implemented only after the central regulator is fully equipped,? Lalit Jain of the SME Pharma Industry Confederation told FE.
A senior executive with a mid-cap company told FE, ?No doubt it is a well-intended move, but there is already a backlog at state levels. If it comes to the central level, the pile-up would only increase, even if DCGI delegates the duty to zonal offices. DCGI should have addressed the issues with those states, against which there have been corruption charges, instead of overhauling the entire system in one stroke.?
The stay is, however, unlikely to impact large pharma companies significantly as a major chunk of their exports is directed to the US and other mature markets.
According to the Centre, delegating the duty to state governments was a stopgap 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.
The DCGI has taken the position 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 nature of WHO certificates originating from India.
