The Hindu Business Line : Central Drug Authority proposal shelved

With small drug-makers complaining against centralisation of authority and State drug regulators, too, concerned that revenue would fly out of the States – the Parliamentary Standing Committee under Mr Amar Singh has rejected the CDA proposal in its present form, a source familiar with the development told Business Line.

The proposal for an autonomous regulatory body at the Centre had been mooted by several Governments earlier. And the Mashelkar Committee was among the more recent advocates for a dynamic and transparent system in synch with the growing pharmaceutical, medical devices and clinical trial segments.

Small cos’ concern

The problem with the latest proposal is that it seeks to be a Central Drug Authority, rather than an Administration.

If all authority is vested with the Centre, it would be difficult for small drug firms spread across the country to go back and forth for renewal or licenses, their follow-ups etc, said Mr T.S. Jaishanker with the Confederation of Indian Pharmaceuticals Industry (CIPI). The organisation had made its concerns known to the Parliamentary committee.

State licensing

Some State drug authorities have been operational for about 60 years, with guidelines and timelines on different approvals; medicines are approved in line with guidance from the Centre, and there is no need to change a system that works, a State regulatory official said.

In Maharashtra, for instance, there are seven licensing authorities in the State. Scrapping them all and a centralising authority in Delhi would mean that manufacturers located here would have to rush to the Centre, at the cost of their time and money, a Health Ministry official pointed out.

At present, new drug approvals are given by the Central regulatory authority, the Drug Controller General of India. Manufacturing licences are given by the local Food and Drug Administrations or State Drug Controllers.

These approvals cost between Rs 750 and Rs 1,250, depending on whether the drugs are on the Scheduled list etc. Renewal of product manufacturing licences comes up every five years and costs between Rs 3,000 and Rs 6,000, again depending on the medicine, a Ministry official said. State drug authorities get revenues of about Rs 20-25 crore from such activities, a Health Ministry source estimated.

The CDA has been treading on thin ice from the beginning, as it was to be an all-encompassing body looking into regulatory issues on drugs, clinical trials etc. This put the DCGI’s office in a spot – would it be absorbed into the CDA or would the post of Drug Controller be raised to head the CDA?

The Centre’s plan was to have a reputed scientific head chair the CDA, rather than a bureaucrat, a source said. But the veto of the Union Health Ministry’s proposal for a CDA comes as a setback of sorts, even as the United States Food and Drug Administration sets up base in India to tackle increased activity from the local pharmaceutical industry.

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