Regulation/Guidelines

Health Ministry Draft Notification To Add 16 Drugs as OTC Under Schedule K of Drugs Rules, 1945

  • 4th July, 2022

According to the latest draft gazette notification, G. S. R. 393 (E), released on 25-05-2022, The Ministry of Health and Family Welfare (MoHFW) has circulated a notification by revising Schedule K of the Drugs Rules, 1945 that permits retailers to sell 16 specific drugs Over-The-Counter (OTC) with a valid license.

The Union Health Ministry will preferably add miscellaneous strengths or forms of 16 drugs, including antipyretic paracetamol 500 mg tabs, antihistaminic or antiallergic diphenhydramine 25 mg capsules, Antifungal Clotrimazole 1%w/w powder, analgesic diclofenac in ointment format, povidone Iodine 5% w/v as an antiseptic and disinfectant agent, among others, under Schedule K of Drug Rules 1945.

As per the Drug and cosmetic rules, the drugs defined under Schedule K shall be free from the provisions of Chapter IV and the regulations made under this act to the extent and subject to the condition defined in that specific schedule.

As per the proposed amendment; In Schedule K of the Drug Act 1945, after the newly added serial number 39 for antiseptic liquid for household use, the related entries will be added under a single serial number, namely – 40.

Here is the list of drugs that need to be sold Over-The-Counter (OTC) by the retailer with a valid license –

Class of Drugs –

  1. Povidone Iodine 5% w/v solution Composition: Povidone Iodine 5% w/v (Antiseptic and disinfectant agent
  2. Chlorohexidine Mouth wash Composition: Chlorohexidine Gluconate 0.2% (For the treatment of gingivitis)
  3. Clotrimazole cream Composition: Clotrimazole 1% w/w cream (Antifungal)
  4. Clotrimazole dusting powder Composition: Clotrimazole 1%w/w powder (Antifungal)
  5. Dextromethorphan Hydrobromide Lozenges (5mg) (Cough)
  6. Diclofenac ointment/cream/gel Each gram of gel contains 10 mg of diclofenac sodium (equivalent to 11.6 mg of diclofenac diethylammonium) (Analgesic)
  7. Diphenhydramine Capsules 25 mg (Antihistaminic/Antiallergic)
  8. Paracetamol tabs 500 mg (Antipyretic)
  9. Sodium Chloride Nasal spray – 0.9% (Nasal Decongestant)
  10. Oxymetazoline nasal solution 0.05% (Nasal Decongestant)
  11. Ketoconazole shampoo 2% w/v (Anti dandruff)
  12. Lactulose solution 10gm/15ml (Laxative)
  13. Benzoyl peroxide 2.5 w/w (Antibacterial for acne)
  14. Calamine Lotion (Antiseptic)
  15. Xylometazoline hydrochloride 0.05% w/v (Nasal decongestant)
  16. Bisacodyl tablets 5mg (Laxative)

Extent And Conditions of Exemptions –

As per the provisions of Chapter IV of the Drugs and Cosmetics Act, 1945, these specified drugs don’t require any prescription of a Registered Medical Practitioner (RMP) and can be sold by retail Over-The-Counter (OTC) with a valid license, subject to following conditions –

  1. A maximum of five days should be allowed for treatment/use.
  2. If the symptoms do not improve or resolve, the patient should visit a Registered Medical Practitioner for further consultation.
  3. In the pack size, the maximum number of doses permitted for five days may not be exceeded per pack.
  4. A Patient Information Leaflet (PIL) may be attached to the packaging of the drug for each pack.
  5. As required by Rule 21(b) of the Licensing Authority for the categories listed in the list, the indication claimed must match what has been approved.

This is in accordance with a draft rule notified by the Ministry. With the notification, the government also noted that the draft rules will be examined after the expiration of a period of thirty days from the date on which the Gazette of India containing the draft rules is made available to the public. The government will consider any comments and suggestions received during this period.

Conditions

In the draft notification for OTC drugs, the following conditions are stated:

  • These described drugs can be sold over-the-counter by retailers without any Registered Medical Practitioner’s prescription only if the maximum duration of treatment or use is no longer than five days. If the symptoms do not go away when using the medication, the patient should consult a medical practitioner.
  • Additionally, the package size of the drug must not exceed the maximum daily dose prescribed for five days and each pack must come with patient information leaflets that explain how to use the medicine.
  • The draft notification also clarifies that the indication claimed should be the same as that already approved by the licensing authority for each drug.

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODQ5MQ==

Download Gazette Notification No. 393 (E) dated 25-05-2022 From Ministry Of Health And Family Welfare

Summary :

To promote self-care without compromising patient health and safety, the Ministry of Health and Family Welfare (MoHFW) has released a draft notification about the list of over-the-counter (OTC) drugs under Schedule K of Drug Rules 1945 and laid down specific provisions for its regulation in the country.

According to the notification, G. S. R. 393 (E) dated 25 May 2022, the Union Health Ministry has issued a list of 16 medicines that can be traded or sold over the counter (OTC) under schedule K by retailers with a valid license. The OTC drugs contains – Povidone Iodine 5% w/v, Chlorohexidine Gluconate 0.2%, Clotrimazole 1% w/w cream and powder, Oxymetazoline nasal solution 0.05%, Sodium Chloride Nasal spray 0.9%, Diphenhydramine Capsules 25 mg, Dextromethorphan Hydrobromide Lozenges 5mg, Paracetamol tabs 500 mg, Diclofenac ointment/cream/gel with 10 mg of diclofenac sodium per gram, Ketoconazole shampoo 2% w/v, Benzoyl peroxide 2.5 w/w, Calamine Lotion, Xylometazoline hydrochloride 0.05% w/v and Lactulose solution 10gm/15ml.