KSRPA asks Govt to amend Rule 123 of D&C Rules w.r.t. Schedule K

KSRPA chief has provided a list of drugs to be deleted from Schedule K and also the reasons for the omission.

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Rules Law Act
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Last Updated on December 14, 2021 by The Health Master

The Karnataka State Registered Pharmacists Association (KSRPA) has urged the central government to amend Rule 123 of the Drugs and Cosmetics Rules 1945. Furthermore, it also called for the inclusion and deletion of certain drugs in Schedule K.

The Association has been communicating in this regard to the Union government and the Drugs Controller General of India (DCGI) since 2014, stating its communication to the concerned authorities.

Rule 123, read with schedule K to the D&C Rules 1945, provides exemption from certain rules for certain drugs. Schedule K specifies the extent of exemptions, said Ashokswamy Heroor, president, KSRPA.

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 have also been amended.

Still, this list of drugs in Schedule K requires a radical change based on the modern lifestyles, pointed out Heroor in his note to the government.

KSRPA chief has provided a list of drugs to be deleted from Schedule K and also the reasons for the omission.

These are Quinine, other antimalarial formulations, Aspirin, Quinine sulphate, Iodo chloro hydroxy quinoline and ophthalmic ointment of tetracycline group of drugs.

Here the reason for deletion is that some drugs are unsafe to use because of increased side effects and drug interactions.

Of the 11 drugs to be included in Schedule K, the Association has indicated that these are antipyretics, anti-analgesics, and anti-inflammatory like aceclofenac, ibuprofen, diclofenac, and piroxicam, and indomethacin.

With regards to vitamins and nutrients, it covers nutraceuticals, calcium carbonate and ferrous sulphate.  

  • In the anti-amoebic and anti-protozoal categories covers Diloxanide furoate, Metronidazole, and Tinidazole.
  • Among the antifungals covered are clotrimazole, fluconazole, miconazole, and ketoconazole.
  • The anti-emetic category will have prochlorperazine, metoclopramide, domperidone, and ondansetron. 
  • The anti-histamine medicines are chlorpheniramine and cetirizine.
  • In the category of bronchodilators are salbutamol, terbutaline, and deriphyllin.
  • In the case of anti-helmintics, which are drugs for de-worming covering albendazole and mebendazole.

The Association also said that these drugs require an exemption from Rule 65(9)(a), which requires a prescription for an RMP for retail sales.

The Association has made a fervent request to concerned authorities to amend Schedule K in the interest of the public with the inclusion and omission of certain drugs.

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