The centre will soon notify guidelines for the implementation of amended Drugs and Cosmetics Act 2008 which sought to enhance penalty for manufacturing of spurious and adulterated drugs, in a uniform manner across the country by ensuring least harassment to the genuine players.

The recent Drug Consultative Committee (DCC) meeting has approved the guidelines, prepared by the expert committee in this regard, in the wake of apprehensions among the industry that new law could be misused by the authorities. The new guidelines, along with standard operational procedures and definitions on substandard and spurious drugs in detail, will be notified after ratification by the DTAB and by the health ministry, sources said.

The Act was passed by the Parliament in December 2008 under which penalties for manufacture of spurious and adulterated drugs have been enhanced. Offences related to adulterated and spurious drugs have been made cognizable and non-bailable. In order to ensure that the enhanced penal provisions are implemented by the authorities in a uniform and justifiable way, guidelines have been prepared in consultation with the drug manufacturers associations so as to outline standard operative procedures for taking action on samples of drugs declared spurious or not of standard quality.

This would ensure that while real offenders are punished with heavy hand, law abiding manufacturers and sellers are not harassed or put to a disadvantageous position, sources said.

"In the case of not of standard quality reports because of minor defects arising out of variations from the prescribed standards or contraventions of other provisions of Chapter IV of the Act, administrative measures including suspension, cancellation or compounding of offences may be resorted to. Prosecution may only be launched where it is justifiably felt that above measures would not meet the ends of justice," according to the guidelines.

Section 36 AC which makes certain offences under the Act cognizable and non-bailable has been inserted to facilitate the arrest of anti-social elements involved in the manufacture of spurious or adulterated drugs. "The section should therefore be invoked with utmost care and only in cases where it is justifiably felt that it is essential to book the culprits for proper investigations in the case," it said.

Importantly, the guidelines mandate for constitution of a screening committee 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 may submit written opinion on the investigation reports regarding their feasibility of taking legal action. The criminal intent or gross negligence should be taken into consideration while recommending actions like prosecution etc. Care should be taken that charges framed are not based on inappropriate provisions which may be difficult to prove in the court of law in the absence of proper justification or evidence. Cases of failing in assay, brand name disputes and non-renewal of manufacturing licence in time should be examined on their merits before recommending prosecution in such cases," it said.