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KSRPA urges Union govt to amend Rule 123 of D&C Rules 1945 for omission & addition of drugs under Schedule K
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Nandita Vijay, Bengaluru
October 25 , 2018
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The Karnataka State Registered Pharmacists Association (KSRPA) has urged the Union government to amend Rule 123 of the Drugs and Cosmetics Rules 1945 to include certain drugs under Schedule K. The Association also sees that while new drugs are added, specific inclusions of some medicines are also warranted under this Schedule.
The Rule 123 read with schedule K to the Drugs and Cosmetics Act 1945, provides exemption from certain rules for certain drugs. The Schedule K specifies the extent of exemptions.
“The government has been constantly adding new drugs to this list and deleting the 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 exemptions also have been amended. Yet this list of drugs in schedule K requires a radical change based on the modern life styles,” said Ashokswamy Heroor, president, KSRPA
Sharing a list of the drugs to be deleted from Schedule K and providing reasons for the same, he said that quinine and other anti malarial drugs should be removed from this category. This is because the state government cannot enter into any agreements with the retailers.
The Schedule C drugs supplied need to be deleted because the registered medical practitioners cannot prepare such drugs any more.
In the case of omitting quinine sulfate from Schedule K list, Heroor said that the drug is unsafe to use because of side effects and drug interactions. On magnesium sulphate’s deletion from the list was attributed to the onset of adverse drug reactions. Further, Heroor noted that Aspirin tablets, iodochlorhydroxyquinoline in the dosage of 250 mg, which is an anti fungal antiprotozol drug used to treat a broad range of skin infections were also found to report side effects.
With reference to the drugs under 13 (a) in Schedule K he said that these formulations were sold only a village reported to have a population of not more than one thousand persons. Moreover, there was not a single licensed pharmacy dealer in the area and under the Drugs and Cosmetic Act this was a violation.
Providing details on the drugs to be included in Schedule K, Heroor said that the 9 to 10 formulations require exemption from Rule 65 (9) (a) which require prescription of a registered medical practitioner (RMP) for retail sales. The first category of drugs are analgesics, anti inflammatory and antipyretic. The formulations under this category are indomethacin, aceclofenac, piroxicam, ibuprofen and diclofenac sodium.
In the second category the drugs are anti spasmodic which include dicyclomine and mefenamic acid. The third category has vitamins and nutrients which include supplements and calcium carbonate and ferrous sulfate. Fourth category includes anti amoebic and antiprotozol drugs like metronidazole single- tinidazole and diloxanide.
The fifth category are the anti fungal drugs like clotrimazole, tofluconazole, ketoconazole and miconazole. The sixth category covers antiemetic: promethazine hydrochloride metoclopramide, ondansetron and domperidone. The seventh is the antihistamines covering chlorpheniramine maleate, cetrizine. The eighth category is the bronchodilators and anti asthmatic drugs like deriphyllin, terbutaline and salbutamol. The ninth category of drugs are anthelmintics covering albendazole and mebendazole. All these drugs needs to be added in the interest of the patients, said Heroor in his communication with the Union government.
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