KSRPA urges govt to amend D&C Rules w.r.t. Schedule K

Inclusion and exclusion of certain drugs under Schedule K Rule 123 read with Schedule K of the D&C Rules 1945 are needed

Law Legislation Act Bill
Picture: Pixabay

Last Updated on September 16, 2020 by The Health Master

The Karnataka State Registered Pharmacists Association (KSRPA) has now called for an amendment to Rule 123 of the Drugs & Cosmetics Rules 1945, besides inclusion and exclusion of certain drugs under Schedule K Rule 123 read with Schedule K of the D&C Rules 1945 provides exemption from certain rules for certain drugs and Schedule K specifies the extent of exemptions.

The government has been constantly adding new drugs to this list and deleting older ones. As the social requirements change, the list of drugs in Schedule K has been altered and the prescribed conditions or the extent of exemption also have been amended. Still, this list of drugs in Schedule K requires a radical change based on the modern lifestyles, said Ashokswamy Heroor, president, KSRPA, in his communication to the Union government.

In the communication, the Association has listed the drugs to be deleted from Schedule K and the reasons for its exclusion from the list. These include Quinine and other anti-malarial drugs. The basis for its deletion is because the state governments cannot enter into any agreements with retailers. In the case of Schedule C drugs supplied, the deletion is there because the registered medical practitioners (RMPs) cannot prescribe such drugs now.

Similarly Quinine Sulfate drug mandates omission because it is unsafe to use on account of more side effects and drug interaction. Magnesium Sulfate too is unsafe to use because of more side effects and drug interactions. There are also a slew of other remedies which are also viewed to be unsafe to use. These include Aspirin and Quinine sulphate, besides iodochlorhydroxyquinoline which is an antifungal of 250mg strength and an ophthalmic ointment under the tetracycline group of drugs.

Also read: 2 schemes for bulk drugs manufacturing in India: Govt

Further, the Association pointed out that under Section 13-A the mention of ‘Drugs are sold only in a village having population of not more than 1,000 persons and where there is no licensed dealer under the Drugs and Cosmetics Act, also needs to be deleted.

On the drugs to be included in Schedule K, the Association’s list includes analgesics, anti inflammatory and antipyretic including aceclofenac sodium, ibuprofen, diclofenac sodium, piroxicam and indomethacin. Heroor noted that these drugs require exemption from Rule 65(9)(a) which requires prescription of RMP for retail sales.

Under the category of anti-spasmodic drugs, the list includes dicyclomine and mefenamic acid. The Vitamins and nutrients category has calcium carbonate, vitamins and nutrients ferrous sulphate. In the anti amoebic and antiprotozoal drugs are metronidazole, tinidazole and diloxanide furoate. Anti fungal drugs cover fluconazole, clotrimazole, kétokonazole and miconazole.  The anti-emetics include promethazine, metoclopramide, ondansetron and domperidone.

The anti-histaminic drugs are chlorpheniramine and cetirizine. The bronchodilators-anti asthmatic drugs cover salbutamol, deriphyllin, terbutaline. Anthelmintics covering albendazole and mebendazole. Heroor pointed out that in the interest of the public, the government will need to amend schedule K going by the reactions of these drugs.

The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.