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Two weeks ago Justice S Ravindra Bhat of the Delhi High Court dismissed with costs the writ petition filed by the German pharmaceuticals giant Bayer Corporation against the Union of India, the Drug Controller General of India (DCGI) and Cipla. The importance of Justice Bhat’s judgment cannot be overestimated. It is a clear — and sharp — judgment that puts paid to attempts by foreign companies to modify India’s regulations to suit their commercial interest.

The judge characterised the litigation as “a speculative foray; an attempt to ‘tweak’ public policies through court mandated regimes” and, in a first of its kind, awarded costs of Rs 6.75 lakh. The amount, far from being punitive, is to be shared by the government and the third respondent Cipla, one of India’s top drug companies. However, the point that the judgment makes is strong: Companies with deep pockets may “achieve short term goals of keeping out competitors through interim orders” but the court will impose ‘realistic costs’.

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IP patent marketing approval DCGI drugs

The way the actual testing works is that the sponsor clears every project with the Drug Controller General of India (DCGI) and, as part of the process, has to have a Management Committee, an Ethics Committee and a Data Safety Management Board; there are then various monitoring committees and the DCGI is training people to ensure these guidelines are being followed. The structures are all there and the larger trials, by the Bill and Melinda Gates Foundation for instance, are being done under these rules. But much of this is self-regulatory and there will be lapses. The rules and their implementation are being strengthened and as the support eco-system gets better, the chances of regulatory failure also decline. In another five years, India will have a very strong clinical trials environment in place.

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