The Federation of South Indian Pharmaceutical Manufacturers Associations is all set to approach the health ministry on Monday demanding safeguards for genuine drug manufacturers as proposed amendment under the Drugs and Cosmetics Act has not clearly defined what is spurious drugs and sub-standard drugs.

While welcoming the step initiated by the Union health ministry to combat the menace of spurious drugs, the manufacturers are objecting to reports of agencies like ASSOCHAM stating that there are over Rs 4000 crores worth spurious drugs in the country. In a memorandum addressed to the Union health secretary, the Federation said that amendments should have been made without provisions that lead to harassment of genuine manufacturers and traders and focusing on booking the real culprits who push the spurious drugs in to the market.

President of the Federation, B Sethuraman said, "Under the amendments made in sections 27 (a) and 27 (c), imprisonment and fine have become mandatory. Such amendments shall open floodgates of undue harassment of genuine persons involved in manufacture or trade of drugs. As per the amendment, a police officer can arrest without a warrant merely on a complaint since the offences have become cognizable."

According to him, under para 11 of Dr R A Mashelkar Committee Report, it is said that the sub-standard drugs in the country confine mainly to the licensed manufacturers. Under para 11.3 (Annexure 14), Dr Mashelkar has given reasons for sub-standard drugs in the market due to improper conditions under which drugs are stored and transported to the market. The report also recommends what action to be taken on sub-standard drugs (para 11.6). When the amendment was made based on the Mashelkar Committee report, this part of the committee report was not taken into account to safeguard the licensed manufacturers, he said.

Sethuraman, who is also the president of the Pharmaceutical Manufacturers Association of Tamil Nadu (PMA), said before notifying the amendments in the Bill , which was already signed by the President of India, the authorities should define what is spurious drug and draw a distinction between spurious drug and drug of not of standard quality (DNSQ). He said a drug could be found to be spurious only if a complaint is given by a patient or doctor or an institution after the drug was not found effective.

On behalf of the manufacturers, he wanted a technically qualified competent authority appointed under the D & C Act only could determine whether a drug is spurious or not. As the police officials are not technically qualified, they should be kept away from acting on the D & C Act and Rules.