Pharmacists want CDSCO to clear ambiguities in D&C Act to enable better pharmacy practice

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To enable better pharmacy practice, pharmacists across the country want the Centre to push for immediate corrective measures aimed at clearing the ambiguities in interpretation of drug laws related to retail pharmacy. This demand comes in the wake of growing concern among the retail pharmacists over the lack of clarity in the Act, which is leading to different interpretation of the law, further complicating the matters.

In a detailed representation sent to the Drugs Controller General of India (DCGI), a community pharmacist Raj Vaidya conveyed his concerns affecting from this situation with questions that were very difficult for the pharmacists to answer in the light of these events. Highlighting one of the major concerns affecting the pharmacists, Vaidya pointed out that ever since the Drugs & Cosmetics (D&C) Act & Rules relating to the stocking and sale of medicines at the retail pharmacy and medical store were made many decades ago, significant changes have happened in the types and dosage forms of medicines, packaging of medicines, technology, trade, etc.

“With such changes happening, many of the drug rules do not specifically fit the present situation, and therefore today there arises several ambiguities in the Rules and their interpretation. What happens with this is that the same rule or situation is interpreted differently by different people and many times by different authorities within the drug control department itself. A simplest example is the answer given to the question, whether the pharmacy can cut a strip of tablet or capsule to dispense part of it to the patient,” he pointed out.

He further stressed that while some say that one cannot cut a strip, some say that one has to cut a strip if the patient needs lesser tablets, while some others say that it is the discretion of the pharmacy whether to cut or not to cut a strip.

Such serious ambiguities exist in plenty of other situations in day to day functioning of a retail pharmacy, and only causes confusion amongst the retailers, patients, and also the drug authorities. An expert from this field, Vaidya believes that it is very important that the CDSCO takes up the exercise of going through the entire set of drug laws and rules applicable to retail sale of drugs, and bring about changes in them, so that not only are they in tune with the present day situation, but also take care of several unanswered questions in the existing set of rules. While also ensuring that the rules are written in such a manner that their interpretation is clear and unambiguous.

He elaborated further that there is a long list of situations like indication by labels or other manufacturer packing, other legal aspects related to retail pharmacy, cash memo, dispensing, prescriptions pertaining to retail pharmacy, which either have no answers in the present D&C Act & Rules, or lead to ambiguous answers and interpretations by different persons. “All this results in great difficulties and confusion in the running of a retail pharmacy and medical store, often resulting in arguments with consumers and waste of valuable time. These changes need to be brought about also taking into consideration patient safety and safe use of medicines. Thus we strongly feel that with a view to safeguard the public interest and to ensure better practice, the Centre should bring clear cut rules relating to these and other issues related to retail pharmacy functioning in the country,” he added.

Source: PharmaBiz


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