India should rationalise, not harmonise, drug laws with global laws: DCGI

The Drugs Controller General of India (DCGI) has come out strongly on simplifying local drug regulatory laws and “rationalising” them in line with international laws, rather than “harmonising” them.

Some aspects of the Indian drug laws are “better than” international laws, VG Somani, DCGI, told the Indian Pharmaceutical Forum (IPF) 2020. He cited the law on patient compensation, which is not available anywhere else in the world.

Even the World Health Organisation (WHO) has cautioned it on harmonisation and joining the PIC/S (Pharmaceutical Inspection Co-operation Scheme), he said, indicating that such a move could lead to over-regulation that could, in turn, affect access to medicines. The WHO has a “human face” and is not involved with trade and intellectual property issues, he later told mediapersons. Joining PIC/S would reduce the burden on regulators in terms of reducing the repetitive nature of inspections by various regulators on drug factories etc, he agreed, but a section of industry is not sure if there is any benefit in it for them.

Adopting best practices

Rubina Bose, Deputy Drugs Controller (CDSCO-West), added that factories sometimes face 7-10 inspections and, in some cases, face inspections despite being pre-qualified by the WHO (which means any government can source from that factory). Harmonisation is a challenge as different stability requirements and specifications are required across different products and factories, she said, calling for adopting best regulatory practices instead.

Broad parameters on quality and many other guidelines can be made uniform, Somani agreed. But, despite the international desire to “harmonise” laws, countries still have their own regulatory frameworks. For instance, Japan has its own high set of standards and does not merely accept USFDA approvals, he pointed out. Europe and Africa have different requirements. And legally, too, there are challenges, he said, pointing to the definition of “adulteration” that varies in different countries.

Pointing out that the EU’s or US’ views on drug regulatory issues are not always right, he said India has been supplying affordable and accessible drugs to over 195 countries over many years now. There is no market or company that does not have problems, he added.

Commenting on the US-EU decision to rely on each other’s inspections, he said the two regulators had been talking for over 20 years and before formalising it. There are no doubts on Indian medical products, he said, adding that when there are complaints people are sent to jail and licences cancelled. Pointing out that quality and manufacturing issues are not restricted to local companies, he said multinational companies also have their issues.

Toward transparency

The DCGI is going to make all such details available on its site, he said, to make it transparent. It is committed to bringing in good regulatory practices in terms of a stable and predictable environment, and is simplifying laws and making compliance automatic without the industry needing a consultant to interpret the rules, he added.

The IPF audience included Satish Reddy, Chairman, Dr Reddy’s Laboratories and President, Indian Pharmaceutical Alliance (a platform for large domestic companies), Sun Pharmaceutical’s Managing Director Dilip Shanghvi, IPA Secretary General Sudarshan Jain, KG Ananthakrishnan, former head of multinational drugmaker MSD India and present Director General of the Organisation of Pharmaceutical Producers of India (a platform for multinational drugmakers) and representatives of other international regulatory authorities.

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