Clampdown on Fake Drugs Manufacturers in India - New Bill Enacted

Posted AtMed India

The Central Government of India is planning to incorporate penal provisions under the Drugs and Cosmetics (Amendment) Bill 2005 to make licensed drug manufacturers who are in the habit of designing or packing their products in such a look-alike manner a criminal act. Officials say the Bill attempts to bring in imitations or substitutes (look-alike) cases where a drug resembles another drug in such a manner that it could be mistaken for the other drug under the definition of spurious drug and hence proposes stringent penal provisions. They also say that such cases would be non-bailable and would result in 10 years of imprisonment and hefty penalties.

The Bill proposes to enhance the period of imprisonment for manufacture or sale of spurious drugs for a term which shall not be less than ten years, which may be extended to imprisonment for life and a fine of ten lakh rupees or three times the value of the drugs confiscated, whichever is more. It has been proposed to provide for a fine of not less than 20,000 rupees under section 28 for non-disclosure of the name of the manufacturer and under section 28A for not keeping documents, etc., and for not disclosure of information. Subsequent offences would be seriously dealt with.

The existing law provides for punishment for imprisonment not less than two years which may be extended to six years and with fine of not less than rupees ten thousand for manufacture and sale of any adulterated drug or manufacture and sale of drugs without a valid licence. Thus the government has proposed to enhance the said punishment which shall not be less than seven years but which may be extended to ten years and with fine which shall not be less than two lakh rupees.

The Bill also proposes to designate one or more Court of Session as Special Court for trial of offences related to adulterated or spurious drugs. Once the new Bill is passed, offences relating to adulterated or spurious drugs would turn cognizable and non-bailable in certain cases. It is also proposed to confer powers upon the police officers not below the rank of sub-inspector of police and other officers of the Central Government or State Government authorised by it to institute the prosecution under the aforesaid Act.

However the small scale drug manufacturers are of the opinion that the government is only protecting the interests of the big pharma by bringing in trademark offences under the spurious drug bill and that if the government was really serious about knowing the exact magnitude of spurious drug manufacturing, they would have ordered for the national survey which was recommended by the Mashelkar committee last year. They also feel that there is no need to mix trade-mark offences and spurious drug manufacturing when there is already sufficient law under trademark and copy rights to handle such cases.

July 25, 2005