On October 23, 2008, India’s Parliament approved an amendment bill to the Drugs and Cosmetics Act, 1956, that increases the punishment for makers of counterfeit drugs. The Drugs and Cosmetics (Amendment) Bill, 2008, will become law upon receiving the President’s approval.
In the amendment, the manufacture, sale, and distribution of fake or counterfeit drugs will be punished by prison time of at least 10 years, and may extend to lifetime imprisonment with fines of whichever is greater: at least Rs 10 lakh (US$20,375) or three times the value of the drugs confiscated. The offense will now also be non-bailable for up to 90 days.
The Drugs Controller General of India (DCGI), India’s main drug regulator, has collected almost 32,000 samples of drugs on the market to test for counterfeits. The results of the extensive testing should be available by the end of 2008. There have been doubts that the DCGI’s office can undertake such an ambitious task with its low manpower and outdated testing facilities. To allay these worries, the DCGI’s office has recently increased its number of drug inspectors, with almost a hundred new inspector positions approved.
It isn’t only the manufacturers of unregistered drugs that need to beware, however. According to the Drugs and Cosmetics Act, drugs that have reduced efficacy or are of substandard quality may also be classified as spurious or adulterated drugs, punishable by the new harsher penalties. Since drugs need to be carefully stored and transported, inadequate storage or distribution facilities may cause some drugs to lose their efficacy and become classified as spurious or fake. Some legitimate drug manufacturers and distributors have expressed concern that problems in storage and transportation may cause them to be charged with selling “spurious” drugs.
Additionally, medicines that are sold with an unapproved change in composition would also be treated as counterfeit drugs. Some companies have removed price-controlled active ingredients from a popular drug without changing the brand name or label, which misleads consumers. Fake packaging and incorrect ingredients may also qualify for punishment under the new law. Pharmaceutical companies should ensure that all storage, distribution, packaging, and ingredients are correct for their drugs in India to avoid the risk of classification as a counterfeit drug.