LEAD STORY. A shot of confidence for Indian pharma, its regulator

The twin challenges of improving the quality of medicines in India and building people’s confidence in the drug regulator are his key priorities, says S Eswara Reddy.

It’s been over three months since Reddy was appointed the Drug Controller General of India. He has, however, clocked over 20 years in the regulatory system, understanding it from within. And it’s time for some confidence-building measures, he says, both internationally and internally.

Though India is feted globally as “pharmacy to the world”, some of the biggest names in the local industry have come in for some serious criticism from foreign regulators. And the reasons vary, from the absence of data integrity to not adhering to other requirements of CGMP (Current Good Manufacturing Practice) norms. Manufacturing facilities in the country are regularly inspected by foreign regulators before a company is given the approval to export to another country.

“I have written to the Health Ministry for India to be a part of PIC/S (Pharmaceutical Inspection Co-operation Scheme),” says Reddy, referring to the informal arrangement between different regulatory authorities on GMP of medicinal products for human and veterinary use.

With 52 participating authorities from Europe, Africa, America, Asia and Australasia, the collaboration harmonises inspection procedures by developing common standards and providing training opportunities for inspectors towards, among other things, reducing duplication of efforts.

It will take time, he agrees, but the move sends out a positive message on adherence to norms and inspections and increases the respect for Indian regulations and the regulator.

But what about individual corruption? Corruption is just part of the problem, he says, adding that the behaviour, attitude and knowledge of drug inspectors needs to change.

Drug inspectors need to take pride in their job, he says, pointing to the negative perception even when drug inspectors do their job well.

Pointing to simple things that make a difference, he elaborates on the “public relations” office the regulator has started, to help anyone who walks in from anywhere in the country, not knowing the language, without an appointment and without knowing whom to approach. It’s as simple as providing them with a glass of water and cup of tea and listening to them, he says, before assisting scientists and start-ups alike, who approach them seeking information for their ventures.

Feet on the street

The efforts at behavioural and cultural changes aside, the drug regulator also faces a shortfall of feet on the street, a gap that needs to be addressed by the larger system of government recruitment. It is a continuous process, says Reddy, admitting that the number of inspectors is not sufficient, despite the 400-odd per cent increase in inspectors in 10 years (from 111 to 525). This year will see about ₹200 crore sanctioned to the States towards capacity-building, he points out.

Fixing policy gaps

Meanwhile, the regulator is also working to fix policy problem areas. Clinical trials have technical and regulatory challenges, he says, adding that sound clinical research needs to be promoted. And that requires a “predictable mechanism and transparency”, says Reddy.

Under the Supreme Court’s watch, clinical trial rules were tightened to bring in multiple levels of scrutiny and attention to informed consent, among other things.

Pre-submission discussions to clarify the requirements of a clinical trial have been brought in, he says. Another suggestion being made is to collapse the approval timeline to 30 days, beyond which it is a “deemed approval” and the clinical trial can begin.

“It is a huge risk for me,” says Reddy, indicating the high stakes, especially if something were to go wrong. But the effort is to build trust and treat the industry with maturity. Non-compliance will bring in suspension, cancellation and blacklisting, he adds. Similarly, with fixed dose combination drugs (involving two or more medicines in one product), a problem that has been festering for over 12 years.

A new FDC policy is under way that streamlines the regulatory pathway for approvals, etc, says Reddy, calling for more “implementable” regulations. A mature regulatory approach that will be tested by how sensibly industry responds to it.

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