Indian drug control system the weakest: Pharma secy

Acknowledging that a lot needs to be done for drug regulation, V K Subburaj, secretary, Department of Pharmaceuticals, said the Indian drug control system is the weakest at present.

"Our drug controller system is probably the weakest today. The government is taking various steps to strengthen the quality mechanism. Not only this, the government is increasing the awareness that all (companies) should move towards high quality parameters," he said on Tuesday. The secretary was addressing the National Pharmaceutical Conclave organised by the Confederation of Indian Industry (CII).

"Health department is already focusing on the quality. It is increasing the number of drug inspectors. It is also increasing the drug controller staff, which is bare minimum right now," the secretary said. To ensure the drug quality, the government banned 344 fixed drug combinations (FDCs) on March 10, after an expert panel found that these drugs lacked therapeutic justification and posed various health risks. More than 100 companies, affected by this decision, moved to the Delhi High Court, which stayed this ban till the next decision. Currently, the court is hearing arguments of both sides.

"Today, only 15 per cent of the products are World Health Organization certified. This should move to at least 50 per cent. If that jumps takes place, people can export such products easily. Consequently, India would get a name as a quality drug manufacturing destination," Subburaj added.

He also said he is trying to revive public sector undertakings (PSUs) of the sector for the past two-three years.

"Our decision-making system is so diverse that I want to revive them, our ministers want to revive them, but somebody in the finance department says don't…someone in the planning commission (NITI Aayog) would say no," he added.

He believes just like some PSUs, which are already functioning well, the others would also function well provided there is 'a continuous monitoring'.

In another session of the conclave, S Eswara Reddy, joint drugs controller, said it will look into the issue of big companies launching their drug products via small companies (subsidiaries) without central drug controller's approval. Moreover, he reiterated central government's stand that state drug regulators approved the fixed dose combinations (FDCs) without asking the central regulator.

PHARMA WOES

• To ensure quality, the government banned 344 fixed drug combinations (FDCs) on March 10
   
• More than 100 companies, affected by this decision, moved to Delhi High Court, which stayed this ban