Even as the Union Health Ministry has notified the Drugs and Cosmetics (Amendment) Bill which makes manufacturing and marketing of spurious drugs a cognizable and non-bailable offence, a section of pharma industry is upset over the fact that the guidelines attached to it is not binding on the authorities.

The industry feels cheated by the health ministry authorities as they feel that with the guidelines not binding on the authorities the new law will be complied more in its misuse by the drug officials, especially the drug inspectors who have been given sweeping powers under the law. There is an overwhelming fear in the industry that since there is no clear-cut definition on 'substandard drug' in the law to differentiate it with adulterated or spurious drugs, there will be misuse of the law.

Since manufacturing and selling of adulterated or spurious drugs are cognizable and non-bailable offence under the new law, the law will be misused and even substandard drugs will be counted as spurious drugs and the manufacturer can be arrested. A drug can become substandard due to several reasons like high temperature, lack of storage facilities at pharmacy outlets, etc, for which the manufacture cannot be held as culprits, the industry feels.

It was under this background that the industry raised a banner of revolt against the Bill when it was passed in Parliament with a voice vote in November last year without taking into account the industry concerns on misuse of several features in the Bill. As the revolt became louder, the health ministry constituted a subcommittee under a senior official to go into the issue and the committee came out with some guidelines to take care of the concerns of the genuine drug manufacturers. Though the officials had told the industry earlier that the guidelines will be binding, that is not the case now.

"The guidelines are just for the purpose of guiding the officials and it is not binding on the drug authorities," said Manoj Tongra, a law expert and a drug inspector in Rajasthan.

Meanwhile, the industry is fuming with anger. "It is a black day for SMEs because injustice awaits each one of them," said SME Pharma Industries Confederation (SPIC) secretary general Jagdeep Singh. SPIC is a confederation of small drug manufacturers in the country.

"Since the Bill was lacking in safeguards for bona fide manufacturers, implementation was deferred by government to address their apprehensions. We were assured by government that binding safeguards would be provided before implementation since offence had been made cognizable with stringent punishment having been mandated. For this the D Roy sub Committee of DCC heard industry in Ghaziabad. To the utter shock and surprise of entire SME sector, the guidelines are deficient and not binding either. How Government claims it will ensure their compliance is not known," he said.

Eighty per cent drugs are to be stored in temperatures below 25 degree Celsius. But there is neither a cold chain nor electricity to support it. Secondly, since major producers of spurious drugs are clandestine manufacturers, labels of licensed manufacturers are used. When such drugs enter the chain, the manufacturer whose labels are misused shall face the music even if he is innocent, Singh said.