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The proposed revamp is driven by concerns, including a rise in antimicrobial resistance (AMR) from self-medication and rampant use of antibiotics purchased over the counter without prescription, the official said.
Schedule H includes drugs that cannot be purchased or sold on retail without a doctor’s prescription. This overhaul will involve updating the list of prescription drugs by incorporating new medicines and formulations that have been introduced in the market in the recent past.
“The issue related to making suitable reforms in the drug regulatory system has been in discussion for quite some time now. The exercise is part of India’s fight against irrational use of antimicrobial medicines, which are used to prevent and treat infectious diseases in humans, animals and plants, including antibiotics, antivirals, antifungals and antiparasitics,” said the official on the condition of anonymity.
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In 2022, a high-level expert committee was constituted by the health ministry to review and revise Schedule H Drugs to recommend comprehensive changes in the drug regulatory regime to reflect global best practices as well as domestic requirements.
Remdesivir, dexamethasone, favipiravir, ivermectin and mebrofenin are some of the drugs that are proposed to be added to Schedule H. Right now, there are around 536 drugs under Schedule H.
The committee had discussed the existing regulatory framework in detail and noted that the drugs that are not included in Schedule G, H, H1 and X can be easily sold in the country without prescription of a Registered Medical Practitioner (RMP) and it is “not in public interest”, according to the documents reviewed by Mint.
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“There are many drugs used for various indications like diabetes, TB, heart disease, pain killers etc which are put in special categories like anti-diabetic, anti-pain relief, anti-depressants, anticoagulant drugs, and cardiovascular drugs of the Drug Rule. However, these drugs should fall in schedule H. So, efforts are being made to streamline this,” said the official.
The expert panel recommended a revamp of the Schedule H. “Schedule H includes drugs of various categories which require prescription of RMP for their retail sale. The Schedule H needs to be updated regularly to incorporate the new drugs introduced in the market from time to time as well as to review the prescription status of different drugs in the present context. Such regular updates are crucial in the current context to address various regulatory challenges leading to irrational use of drugs, including antibiotics and development of anti-microbial resistance,” the documents showed.
Wrong or over-use of these medicines can lead to the emergence of antimicrobial resistance (AMR), which is hard to treat and can cause further infections.
The committee has proposed more than 700 drugs to be added to the Schedule H drugs list in addition to the existing drugs, as per the documents.
The committee also reviewed various aspects of the drugs like their indication, route of administration, international prescription status, abuse or misuse potential, human/ veterinary use, therapeutic/ prophylactic usage etc.
When the committee reviewed Schedule G, it opined that drugs mentioned under this list bear caution that “it is dangerous to take this medicine except under medical supervision”. While Schedule G drugs carry a strong caution about medical supervision, the rules governing their sale did not, in the past, explicitly mandate an RMP prescription for every single sale, unlike Schedule H drugs.
The committee has recommended the addition of several categories of drugs, namely cardiovascular drugs, neurological drugs, respiratory drugs, anesthetic drugs, antiemetic drugs, immunological drugs, genito-urinary drugs, non-steroidal anti-inflammatory drug, and all sterile formulations of any drug to schedule H.