The final recommendations of the expert committee for review of drug regulatory system, including the problem of spurious drugs, are likely to prove a bitter pill for drug trade sector. The committee headed by Dr RA Mashelkar has observed the need for inculcating professionalism among the retail trade and also the making registered pharmacist responsible for the illegal practices that are prevailing in the trade channels. The committee is to recommend measures to make pharmacist accountable for their role in drug distribution system.

The committee is in favour of a review of the current system of leaving the registration of pharmacists and licensing retail outlets with two agencies. An integration of pharmacy profession and retail trade is required for better functioning of pharmaceutical trade. At present state pharmacy councils carry out the registration of pharmacists while drug control department under the Drugs and Cosmetics Act and Rules does the licensing of retail outlets where these pharmacists are deployed. The committee will ask for a review of this system and call for the introduction of the concept of locum (stand-in or substitute) pharmacists to further ensure that the drugs in the supply chain are managed in an appropriate manner, till they reach the patients.

The committee noted an urgent need to implement India specific good pharmacy practices and good storage practices to improve the distribution system and minimize the chances of spurious and substandard drugs entering the supply chain. It wanted pharmacy councils to perform a proactive role in bringing awareness about these concepts and should ensure that their knowledge is linked with the registration under the Pharmacy Act.

The committee observed that in several countries the responsibility of regulating retail sale of drugs is entrusted with professional bodies or state boards that register pharmacists. Continuing education for renewal of registration as pharmacists is also mandatory in several countries. However, the panel has not proposed a concrete solution as to how to integrate the registration of pharmacists and regulation of retail trade.

The committee noted that transportation channels of drugs were also susceptible to be exploited by the unscrupulous elements to infiltrate their spurious products in the distribution channels. It will call for close regulation of secondary market to ensure compliance with Act and Rules, particularly with respect to proper documentation of the movement of products in the course of trade.

At the retail distribution level, the situation can be substantially improved by developing and fostering a professional culture among 'qualified persons' engaged in the retail distribution of drugs. The committee felt that there is a need to inculcate a climate of self-regulation among them. Enforcement of regulations by statutory authorities would always have its limitations in retail distribution scenario since retail sale of medicines is a professional activity involving moment-to-moment conformity with high standards of patient and drug management and a professional commitment. It is not tenable to enforce professionalism through one or two annual inspections by drug inspectors, the committee has observed.