Spurious Drug Bills to Plug Escape Routes of Look-Alike Manufactures

Posted AtPharmaBiz

The licensed drug manufacturers who are in the habit of designing or packing their products in such a look-alike manner may soon be committing a non-bailable offence. The Central Government is planning to incorporate penal provisions under the Drugs and Cosmetics (Amendment) Bill 2005 to make such Â'trade mark offencesÂ' a criminal act. 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.

The small scale drug manufacturing sector has refuted this move by saying that the offence of similar nature has nothing to do with the quality or efficacy of the drug and is only an economic offence that can be handled under the existing trade mark rules.

According to small-scale manufacturers, the government is protecting the interests of the big pharma by bringing in trademark offences under spurious drug bill. "If a small manufacturer is marketing a licensed drug in a make up that resembles a leading brand, he can be charged under the proposed law as a spurious drug manufacturer. The case would be non-bailable and would result in 10 years of imprisonment and hefty penalties. 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," they feel.

The manufacturers feel that the whole issue of spurious drug was raised by the big pharma to pressurise the government for bringing trademark violations non-bailable act under the Drug Laws. According to them, spurious drug manufacturing is a non-issue in this country as the incidence is just a fraction of what has been claimed by Â'vested interestsÂ'.

"If the government was 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. While the big players were very active in lobbying for changes in rules, they were never interested in having a transparent study conducted to find the exact incidence of spurious drugs. The government also never bothered to understand the real situation, but has jumped into the making of Legislation that suits the interest of big pharma," they alleged.

As pharmabiz had reported, 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. It is 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.

The Parliamentary Committee on Health and Family Welfare that is looking into the draft is to finalise the Bill after mandatory consultations with various interested parties like industry, NGOs and the public.

Drugs and Cosmetics Act, 1940, a consumer protection legislation, is mainly concerned with the standards and quality of drugs manufactured in this country and control of the import, manufacture, sale and distribution of drugs and cosmetics.

July 22, 2005