While welcoming overall intention of the new legislation to curb spurious drugs, the SME Pharma Industries Confederation (SPIC) has called for a number of steps by the government to further clarify the very definition of spurious drugs and to eliminate the loopholes in the interpretation of the law.

In a detailed submission to the DCC sub-committee on the issue, the SPIC leaders urged that the thin line between honest and clandestine/habitual offenders should be drawn with care. While supporting the intention of the law, the association cautioned against 'going for overkill' and causing harm to the genuine players in the field.

"Who decides whether the patient died owing to a doctor's negligence or due to an adulterated/spurious drug? And who decides whether the medicine was manufactured badly or lost its properties owing to 45 degree temperature prevalent in summers? Who decides whether the sample tested was genuine or was manufactured clandestinely and labels of bonafide manufacturer were used and it entered the trade chain somewhere?" SPIC representation said.

Noting that definitions under Section 17B (b) and (d) were confusing, the association called for further clarity and amendment in this regard. "There are instances when drugs showing 88 per cent assay in a report of Government analyst has been declared spurious and particulate matter/foreign particles and growth declared as adulterated. Trade Mark issues have also been confused with spurious drug. Bonafide manufacturers have been prosecuted in the past. With enhancement of punishment these shall have grave implications despite DCC guidelines which categorize them as Category B defects, mandating administrative action, which is stringent enough for an honest manufacturer. Prosecution under the DCC guidelines has been sought to be used sparingly when administrative measures fail," SPIC said

While backing the Section 27(b) for a fine of Rs one lakh or more for manufacturing drugs without valid license in the case of clandestine manufacturers, the association said it can be easily misused against bonafide manufacturers also as renewal of license can get delayed owing to different reasons. "The punishment needs to be diluted and waived in case of regular licensed units who are bonafide manufacturers and not deliberate offenders. Administrative action should suffice in their case also. Amendment is required accordingly," it said.

It also cited that a police inspector may not be necessarily well equipped to deal with the complex issue of spurious drugs and hence the law should not allow anybody none else below the rank of drug inspector to discharge the duty. It also called for looking at the provisions with regard to non-maintenance of records or furnishing information or not disclosing the place of manufacture.

"Since it is an acknowledged fact that many government labs are below standard, duly underlined in Dr Mashelkar recommendations, reports generated by them can be inaccurate but it will entail prosecution without bail. Provision for joint testing in the presence of manufacturer may be made prior to launching of prosecution and amendment may be made accordingly," it said.