The Hindu Business Line : Spurious drugs: Amendment worries cos

Mumbai, Nov. 21 The latest amendment to the Drugs and Cosmetics Act, regarding spurious medicines, could not just end up catching genuine manufacturers in its net, but also puts the spotlight on medicine storage and its transportation, say domestic drug-makers.

The Drugs and Cosmetics (Amendment) Bill, 2008 has been passed by both Houses of Parliament and awaits the President’s approval, after which it becomes the law.

Drug-makers fear that the soon-to-be-law tars companies with the same brush, the motive or reason behind the adulteration notwithstanding. A storage glitch that caused a medicine to lose its potency will be penalised as stringently as a spurious drug, said Mr T.S. Jaishankar, Chairman of the Confederation of Indian Pharmaceuticals Industry.

Medicines can lose their stability and potency because of faulty storage or transportation. If law-enforcers pick up such products from retail shops, it would get categorised as an adulterated drug and the drug-maker would land up in jail, he said.

Vitamins need to be stored correctly to be stable, besides there are products that need refrigeration, he said, adding that the norms on storage and transportation in the country were not clear.

Some drug-makers are already facing problems “due to misinterpretation of certain provisions, especially in respect of the definition of adulterated and spurious drugs,” the Indian Drug Manufacturers’ Association (IDMA) said in its recent letter to the Drug Controller General of India.

The industry will submit its concerns by the end of the month, before the Drugs Consultative Committee meets next month, said IDMA’s Mr Daraa Patel. IDMA has asked for a manual to help in the implementation of the law.

Illustrating its problems, IDMA said, field officers sometimes classify drugs that are not of standard quality due to the presence of particulate matter or fungus growth as an adulterated drug, or in other cases, drugs failing in assay of active ingredients are classified spurious drugs, going by the definition of adulterated and spurious drugs under Section 17A and 17B of the Drugs and Cosmetics Act.

Punishment

The punishment for the manufacture, sale and distribution of adulterated and spurious drugs, likely to cause death and grievous hurt, is imprisonment for a term not less than 10 years. But it could extend to imprisonment for life and fine not less than Rs 10 lakh or three times the value of drugs confiscated, whichever was more.

While stringent punishment for persons involved in such offences is necessary, it should not result in harassment to the licensed and bonafide manufacturers of drugs, IDMA said.

Even in isolated cases, the bonafide and the licensed manufacturer is exposed to such severe punishment and even in genuine cases the courts cannot award lesser punishment, as there is no judicial discretion under this Section for awarding less than the minimum prescribed punishment, IDMA said.

They suggest that a drug should not be classified as adulterated, merely on the grounds that it was not of standard quality. The association has also sought clarity on the definition of counterfeits, besides raising concerns on delayed licences of genuine companies being clubbed with the spurious trade and the authority given to the police force to implement the law.

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