The Drugs and Cosmetics Act (DCA) was recently amended to mandate significantly enhanced penalties for those trafficking in “spurious” drugs. While this attempt to counter the menace of harmful drugs is laudable, the term “spurious” itself is loosely worded and could be interpreted to include even legitimately authorised generics. Given recent attempts by multinational pharmaceutical companies to use the ruse of intellectual property enforcement to create additional trade barriers for Indian generic companies, the government needs to be extra vigilant. Particularly so, since such barriers are also likely to impact the availability of affordable medicines to ailing patient populations.

Section 17 (b) (b) of the Drug and Cosmetics Act defines spurious drugs thus: “a drug shall be deemed to be spurious if it is an intimation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bear upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug.”

Based on the above definition, Bayer, a German multinational patentee, dragged Cipla and the Drug Controller General of India (DCGI) to court, arguing that Cipla’s generic version of Bayer’s patented anti-cancer drug was likely to qualify as “spurious” and therefore ought not be granted drug regulatory approval.

Bayer’s preposterous legal attack drew some sustenance from section 17B of the DCA which begins by stating that “a drug shall be deemed to be spurious if it is an intimation of, or is a substitute for, another drug”. Most generics are indeed imitations or substitutes of the original drug! But imitation by itself is not a problem, unless the law states so. And given India’s unique tryst with a patent regime that actively encouraged such copying from the 1970’s and led to the growth of a world-class generic industry that now provides affordable access to a large part of the world, the government, far from enjoining such imitation, must actively promote it.

... contd.