Regulatory experts and industry leaders, representing small scale pharma industries, have opined that the newly notified Drugs and Cosmetics (Amendment) Act will prove to be handing over of machine guns in the hands of monkeys as there are several provisions in the Act which could be misinterpreted and misused by the unscrupulous officials.

It may be recalled that the government had notified the Bill in July this year under which manufacturing and selling of spurious drugs is a cognizable and non-bailable offence. The Act also gives sweeping powers to the drug inspectors, against which the industry has already expressed its concerns to the authorities.

Speaking at a seminar on 'Drugs and Cosmetics (Amendment) Act, 2008: Enforcement, implications and provisions' in Indore recently, the speakers said that the weapon of prosecution should be used sparingly and cautiously and that genuine licensed manufacturers should not be harassed. The Indian Pharmaceutical Association, Madhya Pradesh State Branch, Indore (IPA, MPSB) organised the seminar which was inaugurated by Justice (Retd.) V S Kokje, former governor of Himachal Pradesh. Sumitra Mahajan, MP from Indore, also attended the inaugural function.

In his inaugural address, Kokje emphasized that SSI must be protected or otherwise the countrymen shall have to look only at MNC's for even medicines meant for cough and cold at high prices.

Dr S P Adeshra, ex-commissioner, FDA, Gujarat, elaborated on four corners of drug regulation: public; government; manufacturer/Trader; and regulatory. He expressed that 1993 DCC guidelines are still part of recently issued DCC guidelines after Amended Act, the weapon of prosecution should used sparingly and cautiously and that genuine licensed manufacturers should not be harassed.

He also pointed out that data needs to be complied on the accuracy of test reports of government labs as they generally varied from the reports of CDL when a sample is challenged by a manufacturer. He was also of the opinion that Drugs (Amendment) Act 2008 was like handing out machine guns to monkeys.

S W Deshpande, ex-joint commissioner, FDA and director general AIDCOC, elaborated on the unintended consequences of the Amended Act especially of the provisions U/s 36AB and 36AC. He also expressed his concern about misinterpretation of definition of spurious drug by classifying not of standard quality drug as spurious/adulterated. This will now cause great hardship to industry in general and small scale industry. Severe restrictions on bail, misinterpretation and drafting error in Section 36 AC (b) will be a great risk to SSI and need to be reviewed and reconsidered. He was equally concerned about the involvement of police, indirectly u/s 32(1)(b) for institution of prosecution.

Jagdeep Singh, president, Punjab Drug Manufacturers' Association and secretary general SPIC, narrated various problems of pharma SSI besides the Amended Act. He was of the firm view that MNCs influence change in policy/law in various countries including India to get rid of SSI which offers competitiveness to their high priced brands. He stressed that SSI should remain united.

J R Agarwal, convenor of the seminar, said that drug authorities in the country have double standards in the matters of invoking penal and/or administrative provisions against MNCs' as compared to SSI.

He suggested that the CDSCO and all SLAs' be connected through net in ensuring prompt recall of really defective medicines, government testing labs, which are not reasonably upgraded with equipments and staff, should be de-notified and the amended provisions should be reviewed seriously with participation of national and regional pharma SSI associations.

A Krishna Dev, deputy drugs controller, CDSCO (Retd) and Dilip Chincholikar, Licensing Authority, FDA, MP also spoke on the occasion.