Drug manufacturers are apprehensive that the recent amendment to the Drug and Cosmetic Act may be misused by state drug controllers since offences related to spurious drugs are now non-bailable. In order to put a check on such malpractices, they are stressing on incorporating checks and balances in the rules that the health ministry will frame for the implementation of the amendment.
Acting on the fears expressed by the industry members, the Drug Controller General of India (DCGI) has framed a set of model guidelines and has asked state drug controllers to use prosecution sparingly and judiciously. ?Prosecution should be launched where administrative measures have failed to have the desired effects,? the DCGI has communicated to state licensing authorities. Further, a sub-committee under the DCGI has categorised offences based on the type and degree of severity and has also made a distinction between spurious drugs, grossly sub-standard drugs and minor defects. The guidelines direct that Section 36 AC, which makes certain offences under the Act cognizable and non-bailable, should be invoked with utmost care.
The DCGI has also asked state drug control departments to constitute screening committees, comprising at least three assistant drug controllers or higher ranking officials, to examine the investigation reports of the cases where prosecutions are to be launched. ?The (screening) committee may submit a written opinion on the investigation reports regarding their feasibility of taking legal action,? say the guidelines.
However, drug manufacturers fear that since the guidelines are not binding on state drug licensing authorities, it may not prove to be fully effective in protecting framed scrupulous drug makers. Drug manufacturers are currently in the process of drafting an appeal, to be submitted to the health ministry, request the incorporation of provisions of checks and balances in the rules related to the Act, or at least include in the directive that state licensing authorities cannot deviate from the guidelines.
Constitutional experts are divided on the prospect of whether such a set of guidelines can be made a part of the rules which would be framed subsequently to facilitate the implementation of the Amendment Act and consider it a grey area. Two of the analysts FE spoke to, said the rules cannot go beyond the scope of the Act and in this case, these set of guidelines will remain recommendatory and are unlikely to become a part of the rules. As neither the amendment nor the original Act provides flexibility for a classification of offences, at this stage it is improbable that the guidelines, in its entirety, can be made part of the rules, said an expert. Another expert said there have been precedents where, through the intervention of the judiciary, facilitating clauses have been added in the rules for explanatory purposes. Health ministry officials feel that the new law should be a given a chance.
Under the Drugs and Cosmetics Act, 1940, control over the manufacture and sale of drugs is exercised by the state licensing authorities. Inspections and raids by drug inspectors ensure compliance of the conditions of licences and the drawing of samples to check the quality of drugs. Legal and administrative actions under the DCA and rules for violation of the provisions of the Act are taken by the state licensing authorities. These are normally initiated on the basis of test reports of government analysts declaring the drug samples as below the standard quality. Commenting on the suggested amendments in the Act, PRS legislative research, Centre for Policy Research, had said, ?The Mashelkar Committee made various recommendations with regard to strengthening the drug regulatory system and the problem of adulterated and spurious drugs. Whereas several of these recommendations are being implemented through these bills, neither bill addresses the recommendations related to strengthening drug regulation at the state level?. The amendment in DCA, enhancing the penalty for offences related to spurious and substandard drugs, was notified this August.
