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IPA wants Centre to bring in clarity on Rule 96 & Schedule G drugs under Rule 97

Suja Nair Shirodkar
Tuesday, July 14, 2015, 08:00 Hrs  [IST]

Keen on getting clarity on certain provisions pertaining to the Drugs and Cosmetics (D&C) Act and Rules, the Indian Pharmaceutical Association (IPA) recently made a detailed representation to Central Drugs Standard Control Organisation (CDSCO) officials in Delhi seeking their intervention. Interestingly, CDSCO had called upon the meeting with key stakeholders in mid-June to deliberate over key issues and suggestions relating to the draft amendments to the D&C Act and Rules, of which IPA was also an integral part.

During their meet with the joint drugs controller, IPA highlighted specific points that were leading to considerable confusion among the stakeholders. One of the prominent issues raised by the Association was on the Rule 96 and rules relating to labelling of medicines. This demand comes in the wake of confusion among the pharmacists over the applicability of this rule.

Pharmacists allege that while the Rule 96 states that proper name of the drugs should be printed or written in more conspicuous manner than the trade name, in practice many products carry trade name more prominently than the actual name. Kaushik Desai, general secretary of IPA stressed that there is also a lack of proper labelling of the medicines in terms of its matter and readability, which needs to be corrected.

“Not only the consumers but even the pharmacists and medical practitioners have to struggle sometimes to read the contents of the products, especially on the strips of the tables or capsules. We strongly feel that the Centre should immediately address our concerns relating to rules of readability of the label that deals with font size, use of ink colours and other minute details for ease of service. Likewise, there is no uniformity in writing the brand names for both the single ingredient as well as FDCs, as only some drugs include the potencies in the brand name. Thus to reduce chances or incidences of error Centre should specify and include the potencies in the brand name,” stressed Desai.

He further observed that keeping in lines with consumer welfare the Centre should also take pro active steps towards including relevant information such as major side effects do's and don'ts on the product label of non prescription drugs as well, since these drugs are for self medication making it vital to have medicine information for consumer safety.

Another key issue raised by the IPA was the provisions relating to Schedule G drugs under rule 97, which basically deals with insulin, metformin, glibenclamide, antihistamines and some anti cancer drugs including list of almost 50 drugs. Desai pointed out that there is lack of clarity on whether these drugs are prescription or over the counter drugs in spite of the serious nature of its use. This doubt stems from the fact that while the labels of these drugs clearly mentions warning that they should be taken only under medical supervision, they do not contain warning as per Schedule H drugs, which are prescription only.

He stressed that this puts the chemists under a difficult spot as they are not certain about the nature of the drugs that fall under Schedule G, i.e are they prescription only or can they be dispensed as OTC. As per the rule 65,2[(9) (a)], substances specified under Schedule H or X shall not be sold by retail except on and in accordance with the prescription of a registered medical practitioner, causing confusion over the applicability of Schedule G.

To simplify and bring in clarity on this matter, IPA has suggested the Centre to recategorise the medicines as per prescription, OTC etc.


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