The Indian Drug Manufacturers Association (IDMA) will soon appeal the Union Ministry of Health and Family Welfare to formally notify the Drug Controller General of India's (DCGI's) guidelines on spurious drug, which specifies the action to be taken by the state drug control officers on category basis - spurious, substandard and minor defects.

The new guideline suggesting the state drug control organizations to have an internal mechanism of checks and balances to ensure that law abiding manufacturers and traders of drugs are not harassed or put to a disadvantageous position, has been issued in August, 2009, considering the apprehensions of the drug manufacturers on the issue.

However, the Association feels that the guideline has to be incorporated into the latest Drugs & Cosmetics (Amendment) Act, in order to ensure that the state drug control organizations strictly abide with the guideline.

"Since the rational measures suggested by the ministry is only a guideline, we fear that the state regulators are not mandated to follow the mentioned procedures while taking action in various cases. We will request the government to make the guideline a part of law so that the genuine manufacturers are ensured not to be in trouble in future," said S V Veeramani, chairman, SME Committee, IDMA.

The guideline classifies the defects in pharmaceutical products as three categories, A, B and C and suggests that the state authority should appoint a committee to review each case before proceeding with prosecution. This, in effect, is expected to save the genuine manufacturers from facing severe legal measures for minute defects or defects caused to the medicine in uncontrollable circumstances.

The industry associations including IDMA have been asking for review of the spurious drug law in the amendment Act, as Section 36 AC makes certain offences under the Act cognizable and non-bailable, which are as stringent as POTA and TADA. Following the opposition from the industry, the DCGI has summoned views from the associations and has also discussed options to provide justice to the legitimate drug manufacturers, though the law has been passed by the Parliament and got signed by the President of India.

The guideline for state drug controllers came as a result of the discussions between the regulatory body and the drug manufacturers, though the law cannot be changed and is expected to be notified anytime now. The IDMA is working on a representation to be submitted to the ministry seeking the guideline to be included in the law and is expected to meet the top officials in the ministry soon, informs Veeramani.

The new guideline asks the state drug control departments to constitute screening committees comprising of at least three senior officers not below the level of Assistant Drugs Controllers or equivalent to examine the investigation reports of the cases where prosecutions are proposed to be launched. The committee will have the onus to submit written opinion on the investigation reports regarding their feasibility of taking legal action, by considering various factors. The inspectors should launch prosecutions on the basis of written permissions of the controlling authority and this authority in turn shall consider the recommendations of the screening committee while taking final decision in the matter, according to the guideline.