The M P Small Scale Drug Manufacturers Association has suggested a nationwide deliberation on the final recommendations of the Mashelkar Committee for Review of Indian Drug Regulatory System before legislative changes are introduced into the existing system. Addressing the final meeting of the committee held here last week, representatives of MPSDMA expressed serious reservations against arming ill equipped, inadequate, weak enforcement agency with stringent powers. The committee that is fine-tuning the report is to submit it before the government in the second week of November.
The association felt that improper method of testing, use of inferior quality chemicals/ reagents, business rivalry, incorrect interpretation of law and improper ex-factory storage facilities are the major reason for a drug sample reported as either spurious or NSQ. "Before proposing enhanced penalties, the entire machinery should be set right, else further misuse and abuse of power will happen", they warned.
According to them, the regulatory agency, already short of manpower and infrastructure, is pursuing baseless prosecutions pending in courts and are not finding time to monitor market forces.
The association wanted the constitution of a committee under the law with participation of SSI sector at state and central levels to refer all matters where either departmental/ legal action is proposed by the regulatory authorities. These committees should take the final decision on all such cases and the committee should give an opportunity for personal hearing to the industry / trade, they said.
The association, a constituent body of the Confederation of Indian Pharmaceutical Industries - SSI (CIPI), wanted the committee to take note of the practice of big pharma companies sponsoring activities of medical associations and high value incentives to individuals. It wanted the committee to ensure that all government hospitals, dispensaries and medical stories are complying with the storage conditions. "Proposed compounding in the matter of minor contravention, should not be more than Rs 1,000 and this provision may be incorporated under Rule - 85", they suggested.
On the proposal for a Central Drug Authority (CDA), they said that the SSI is happy with the present set up, meeting the constitutional requirement and wanted it to be continued and upgraded to the desired level.
The association felt that committee should first ensure necessary infrastructure and then finalise the modalties of CDA. "The modalties should be deliberated at the national level and then approved, if necessary. Overnight creation of CDA can result in chaos in pharma industry", they said. Office bearers of the association informed that the committee has assured to consider their suggestions while preparing the final report.