The drug industry's proposal to get to include vitamin and calcium preparations under the Schedule K of Drugs & Cosmetics Rules is summarily rejected by an expert sub group of the Drugs Technical Advisory Board (DATB) which looked into the matter, it is learnt.
The vitamin preparations are covered under Schedule P that prescribes storage conditions to protect their potencies. The experts noted that such storage conditions would not be available in groceries or kirana shops. They felt that some of these preparations fall under Schedule C (1) for which expiry dates are required to be marked. Such drugs need to be checked by a drugs inspector and since they cannot keep a watch of kirana shops, inclusion of vitamin preparations Under Schedule K was not recommended.
The Organisation of Pharmaceutical Producers of India (OPPI) had requested for addition of several such preparations under Schedule K of Drugs & Cosmetics Rules 1945 some time back. The sub-group was also against considering requests of OPPI for the inclusion of mouth ulcerants, senna preparations and topical antifungal and antibacterial preparations in the list of OTC drugs.
The sub-group observed that the topical preparations are not covered under Schedule H and hence are in the strict sense OTC drugs. "Most of these preparations contain corticosteroids, antifungal antibiotics and are classified as Schedule C (1) drugs. Applications of such preparations on skin conditions poses risk of systemic adsorption into blood. Though they are not prescription drugs, they are generally bought after a doctor's advice about its usage. Hence the distribution and sale of such preparations through licensed chemist outlets is very much necessary. It cannot be included in Schedule K," they reasoned.
In the case of mouth ulcerants, the experts felt that mouth ulcers being a serious condition caused due to "stomatitis" and other causes need consultations and advice of a physician. "Self-medication is not recommended. Medicines for such use generally contain antibiotics, steroids, which are not suitable for inclusion in Schedule K."
The DTAB is however in favour of including antiseptic lotions, medicated mouthwashes and mouth rinse in the list of Schedule K drugs.
The DTAB is to allow inclusion of psyllium and flavoured preparations of psyllium packed in sealed retail packs, which are duly sanitized, also in the list of OTC drugs. However, preparations of senna are not recommended as senna preparations can cause adverse drug reactions. "Long term use of senna by way of self medication is not good due to its side effects and safety issues including stomach irritation, griping pain and loss of intestinal ability to produce vitamin K which is very much required for maintaining blood clotting time," the sub-group has noted.
According to highly placed sources, the recent meeting of DTAB did consider the revision of Schedule K in a detailed manner. However, they failed to reach at a decision as the expert committee was divided over several clauses in the present rules which call for exemption of 20-A licence requirements for sale of household remedies listed under item 13 of Schedule K to only villages whose population is less than 1000.
While the committee members felt a need for some amendments in this clause, the OTC committee of OPPI demanded a deletion of this condition.