The Drugs Technical Advisory Board of the Union Health Ministry, the highest authority under the ministry on technical matters, has recently recommended to the government to amend the qualification of competent person under Rule 64 of Drugs Rules, 1945 to allow science graduates to manage wholesale drug premises under Forms 20B and 21B. The Board recommended that qualification of competent person may be a registered pharmacist or a degree in science with two years’ experience in dealing of drugs including six months online certificate course recognized by PCI, NIPER, Skill Development Council, etc for the purpose. As per the existing Rules, the competent person should be a registered pharmacist, or one who has passed the matriculation examination or its equivalent examination from a recognised Board with four years' experience in dealing with sale of drugs, or one who holds a degree of a recognised university with one year's experience in dealing with drugs. The new recommendation by the DTAB is in deviation from the earlier proposal that the qualification of the competent person should be with pharmacy background only i.e. D. Pharmacy/B. Pharmacy/M. Pharmacy/Pharm D/Registered Pharmacist for grant of Wholesale Licence(s) on Form(s) 20B/ 21B/ 20G, and to delete the other qualifications like matriculation examination or its equivalent examination from a recognised Board with four years’ experience in dealing with sale of drugs or degree of a recognised university with one year experience in dealing of drugs. While recommending the amendment, the Drugs Technical Advisory Board argues that the move is necessary to strengthen the supply chain and ensure drug quality, safety, and efficacy in a modern, complex pharmaceutical landscape. But, the fact remains that there is no shortage of qualified pharmacists in India to justify such an amendment.
Quite expectedly, the pharmacist associations in the country are up in arms against the Drugs Technical Advisory Board recommendation. They contend that the move is fundamentally flawed and violates the Pharmacy Act 1948, which legally entrusts the handling and supervision of medicines to registered pharmacists. The associations point out that Rule 65(2) already mandates the personal supervision of a registered pharmacist for drug sales, making the proposed broadening of the competent person definition contradictory to existing statutory requirements. By allowing non-pharmacy graduates into these roles, the associations argue, the government is compromising the legal framework established to protect public health. Another primary concern raised by the associations is the vast difference in academic curricula. While pharmacy education focuses on technical subjects like pharmaceutics, pharmacology, and clinical pharmacy, B.Sc. programmes do not cover these specialized areas. There is no direct linkage between a general science degree and professional pharmacy practice. They warned that allowing individuals without formal pharmaceutical training to manage drug supplies could lead to a surge in medication errors, antimicrobial resistance, and irrational drug use. Yet another valid point raised by the associations is the reliance on a six-month online certificate course, as such a brief programme cannot replace years of rigorous professional education and hands-on training. They argue that this amendment would lead to a significant dilution of technical standards within the pharmaceutical sector and will undermine the hard-earned qualifications of thousands of pharmacy professionals across the country who are specifically trained to handle the complexities of modern medicine. There can be no two opinions about the fact that dispensing and managing medicines requires comprehensive knowledge of pharmacology, drug interactions, side effects and dosage calculations. This kind of expertise cannot be replicated by a short-term online course. Surely, the role of a competent person is too critical for public safety to be handled by those without formal pharmacy education. The Union Health Ministry should take the pharmacist associations into confidence before making any hasty action on this Drugs Technical Advisory Board recommendation. |