States oppose centralised pharma regulator

Drug regulators in various states and a section of the pharmaceutical industry are opposing Health Minister Anbumani Ramdoss's plans to transform Indian drug regulatory system on the lines of the autonomous US Food and Drugs Administration (USFDA).

The regulators say that the Drugs and Cosmetics Amendment Bill, 2007, does not provide for autonomy in the drug regulatory mechanism, but attempts to make way for more bureaucratic interventions in administrative as well as technical matters.

The small-scale drug makers who thrive on region specific sales are also against the move to centralise the licencing system for manufacturing units.

The regulators have been irked by the proposal to do away with two technical committees - Drugs Technical Advisory Boards (DTAB) - on modern medicines and ayurveda and entrusting of the responsibilities to the five-member Central Drug Authority.

According to All India Drugs Control Officers' Confederation (AIDCOC), the proposal to establish CDAI is a marked shift from the existing Act wherein implementation, including licencing is done by the state government and the responsibility of legislation, policy, import and approval of new drugs is handled by the central government.

"This practice is followed from the enactment of Drugs and Cosmetics Act, 1940, and is necessary as the the subject of Drugs figure on the concurrent list of the Constitution," SW Deshpande, honorary director general, AIDCOC says.

"Manufacture, sale and distribution is a composite activity and a single agency should be responsible for monitoring the activities of manufacturers, distributors and retailers. However, the Bill envisages two different licensing authorities, CDAI for manufacturing and licensing, and state drug authorities for sales licenses. This will make spurious drug investigations difficult as state officials will not have the powers to inspect manufacturing sites. These difficulties are already being experienced in Maharashtra," Deshpande adds.

Small drug makers say centralisation will make filing of applications and filing appeals against any adverse orders from licencing authorities difficult for hundreds of units that have only state level presence.

"Even in the US, state-level drug authorities can give manufacturing licences to drug makers who have sales only in the particular state. Such companies need not apply for a central licence under USFDA. The proposed Bill is intended at killing small-scale manufacturing sector," Lalit Kumar Jain, vice-chairman, SME Pharma Industries Confederation (India) said.

Both drug officials and small scall drug manufacturers are in the process of rallying the support of Parliamentarians and state governments in their opposition to the CDAI Bill.