New Delhi: In continuation to the efforts of the drug regulatory experts to amend the Drug Rules, 1945 and incorporate necessary provisions to decide a drug to be declared as over-the-counter (OTC), the Drugs Technical Advisory Board (DTAB) has recommended to constitute a sub-committee.
The sub-committee is to examine the matter with reference to various conditions based on which status of a drug as an OTC is decided. It is also envisaged to develop a detailed mechanism for the drugs to be considered under the category. The ministry of health has issued a draft amendment in the Schedule K of the Drugs Rules, 1945 in this regard, on May 25, 2022.
The Board also recommended a comprehensive revisit of this draft notification for which international guidelines may also be considered and the sub-committee should submit its report to the Board.
The Ministry in the draft amendment in 2022 listed around 16 drugs to be declared to be exempted under Schedule K and laid out conditions of exemptions under the rules so that these drugs can be sold by retailer OTC without prescription of a Registered Medical Practitioner (RMP). The conditions include that the maximum duration of treatment or use should not exceed five days, if the symptoms do not resolve the patient should consult RMP, pack size may not exceed the maximum doses recommended for five days, among others.
The DTAB, in its recent meeting on January, 2024, was apprised regarding the draft notification and individual applications from some companies including Intermed Laboratories Private Limited for diclofenac diethylamine transdermal patch 200 mg, Reckitt Benckiser Private Limited for acetylsalicylic acid effervescent 500 tablets, and Glenmark Private Limited for dextromethorphan HBr lozenges 50 mg, mometasone furoate nasal spray 50 mcg.
“DTAB deliberated the matter and recommended to constitute a sub-committee to examine the matter with reference to various conditions based on which status of a drug as an OTC is decided and a detailed mechanism is to be developed for the drugs to be considered as OTC,” said the Board.
It may be noted that the Drugs Consultative Committee (DCC) has appointed a sub-committee under the chairmanship of NK Ahooja, drugs controller of Haryana to recommend a suitable amendment in the Schedule K, which submitted its report a few years back.
The sub-committee opined that there is an urgent need for defining the OTC drugs and to lay down specific provisions for the regulation of OTC drugs in the country. It also recommended that the definition for OTC drug must be laid down in the Drugs & Cosmetics Rules 1945; basic characteristics of OTC Drugs should be incorporated; classification of OTC drugs into OTC-1 and OTC-2 based on the extent of evidence of safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, present supply chain mechanism, socioeconomic conditions of the country; and preparing an initial list of OTC drugs.
It also recommended forming regulations on switching of prescription drugs to OTC drug, new OTC drug approval; distribution and sale of OTC drugs; and advertisement of OTC drugs
The report was considered by the DCC in its 57th meeting held on August 8, 2019, and recommended that the recommendations of the Subcommittee should be considered for suitable amendment in the Schedule K of the Drugs and Cosmetics Rules, 1945 to incorporate necessary provisions for such drugs for providing exemptions from requirements of Sale license/ prescription of RMP etc. subject to appropriate conditions.
The DCC further recommended that the subcommittee should identify such a list along with conditions and frame a draft for amendments in the Rules.
The matter was also discussed in the 87th meeting of DTAB held in November 2021, following which the list of 16 drugs were published as draft notification in May, 2022.
The Board had also recommended that a proposal for adopting best practices with respect to the dispensing of drugs by various professionals should be prepared for further consideration.
