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Pharmacist associations from across the country have urged the Union ministry of health and family welfare not to allow existing wholesale druggists who are mostly non-pharmacists to remain in the wholesale drug trade once the amendment to Drugs and Cosmetics Rules, 1945 is effected.
The associations, however, have welcomed the ministry's initiative proposing substitution of the proviso to clause(ii) of sub-rule (2) of rule 64 of the Drugs and Cosmetics Rules, 1945. It means once for all 10th pass with four years experience or graduates with one year experience can no more be registered with the state licensing authority as competent person after this amendment and hence not eligible to get wholesale licence.
In a letter to under secretary (drugs), ministry of health and family welfare, the Maharashtra Registered Pharmacists Association (MRPA) has appreciated the ministry's move to consider only registered pharmacists for grant of wholesale drug licence once the amendment is enforced.
MRPA urged the ministry to repeal the proposed proviso to amendment i.e. “provided that the persons already registered with the state licensing authority as competent person for the purposes of grant of license in Form 20B and 21B or both prior to the coming into the force of the Drugs and Cosmetics (Amendment) Rules, 2016 shall continue to be considered as a competent person for the said purposes” and a registered pharmacists should henceforth be compulsory for grant or renewal of license in Form 20B or 21B or both.
This will ensure proper handling, storage, preservation and quality assurance of all medicines and medical devices by duly qualified and registered pharmacists and protect public health by making available best quality medicines for safe, effective and economic therapy, said president of MRPA Kailas Tandale.
In India there are about eight lakh unemployed registered pharmacists eagerly waiting for job to serve the community. We, therefore, appealed to the ministry to consider this suggestion in greater interest of health and happiness of people of the country, who deserve world class pharmaceutical care by all means, said Tandale.
Federation of Indian Pharmacists Organisations (FIPO) has also welcomed the ministry's initiative to issue wholesale drug licence to registered pharmacists henceforth. The ministry's proposal to consider existing drug wholesalers who have received licence from state licensing authority as competent persons to continue the trade was opposed by FIPO.
All drug trade licences whether they are meant for retailers or wholesalers should be given to pharmacists only. Allowing non-pharmacists in the trade would result in lapses in storage and preservation of medicines affecting its quality. Non pharmacists hardly know about safe and secure handling of the sophisticated drugs. D&C Rules, 1945 were enacted when there were shortage of pharmacists but nowadays we have adequate pharmacists, hence allowing old practices to continue does not make sense. Over the years complex drugs have been introduced which need to be stored properly. They require special handling because of their inherent toxicities. Its high time the government should grant wholesale drug licence to pharmacists who are well versed in dealing with drugs, said president RS Thakur.
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