You may soon get to buy non-prescription drugs at a friendly neighbourhood store

The Drugs Technical Advisory Board (DTAB) decided last month that several medicines that do not need a prescription may be sold at retail outlets, three people aware of the matter said. These include analgesics, anti-allergics, antihistamines, cough syrups, laxatives, antifungal products, and certain asthma drugs. Though retail stores won't need a pharmacist like regular chemists, they will need to secure a licence for selling these medicines, also called over-the-counter (OTC) drugs.

“The government is finalizing the list of OTC drugs and products which can be sold at retail shops. The government has been working on this for a long time, and a final decision is to be taken shortly," said one of the three people cited above, who attended the DTAB meeting.

Relief for consumers

The move spells relief for consumers who can pick up these medicines from just about anywhere, but also casts a pall of gloom over tens of thousands of chemists staring at loss of sales.

Queries emailed to the Union health ministry remained unanswered.

New regulations will define OTC drugs and formulate a separate schedule for them, the second official said. "Right now, OTC drugs are not defined or covered under the Drugs Rule, 1945. Once these regulations are in place, the public will be aware of what OTC drugs are, and what types of drugs can be purchased without a prescription, the official said. “The move is aimed at ensuring accessibility and availability of OTC drugs to the people even in the interiors of the villages and remote areas," the official added.

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The All India Organization of Chemists and Druggists (AIOCD), which represents 1.24 million members and the Indian Pharmaceutical Association representing 13,000 members, have protested against the plan ever since the government floated the idea of selling OTC drugs at retail shops years ago.

'Where will we go?'

“Where will we go? This will put the growth of pharmacists at risk," said Rajiv Singhal, general secretary of AIOCD. "We are going to submit our representation to the government to seek a transparent and balanced approach in finalizing the sale of OTC drugs at retail level and involve stakeholders like the Indian Medical Association, doctors and Indian Pharmaceutical Association (IPA) before finalizing the change," Singhal said, adding OTC drugs at retail stores may also lead to misuse. The government must share the list of retail OTC drugs with chemists so they can provide feedback on the pros and cons of the decision, he added.

“The sub-committee has prepared a list of OTC drug items. The government will now re-issue a draft notification on OTC drugs regulation, take stakeholders' comments before giving the final nod," the third official added.

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In 2022, the Centre had issued a draft notification permitting the sale of 16 specific OTC drugs without a prescription by retailers with a valid licence, a move that chemists' bodies have opposed since then. In 2024, the DTAB formed a sub-committee to develop a detailed mechanism for the drugs to be considered as OTC.

DTAB agreed with the sub-committee's recommendations. “Legal provisions to be enabled under Drugs Rules, 1945 along with manner of submitting application, prescribe the licensing requirements for the sale of OTC drugs which does not require the supervision of registered pharmacist, requirements for considering a drug as an OTC, labelling requirements, etc. and incorporation of a separate schedule," the meeting's minutes showed.

Possibility of abuse

Experts agreed on the need for OTC drug regulations.

"These drugs are generally regarded as safe within their therapeutic dosage and therefore, 'responsible people' can use them," said Dr. Y.K. Gupta, who has headed the All India Institute of Medical Sciences' pharmacology department. However, he noted that many Indians may not be educated enough to choose these medicines wisely, and hence, there is a possibility of abuse or overuse.

The decision will make OTC drugs widely available to the public, Gupta said, while pointing to the easy availability of even prescription drugs and antibiotics over the counter. "We have to have a balanced approach in terms of accessibility, availability and avoiding inconvenience," said Gupta, who is also the national scientific coordinator of India's pharmacovigilance programme to ensure drug safety.

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In several countries, a large number of drugs are available off the shelf without a prescription. According to AIOCD's Singhal, India sees annual pharmaceutical sales of ₹1.98-2.3 trillion, out of which OTC accounts for ₹30,000-40,000 crore.

Dr. Suranjeet Chatterjee, senior consultant of internal medicine at Apollo Hospital said the only benefit is easy availability of OTC drugs, with some downside.

Downside

“There could be a misuse of OTC drugs, and people can take the drug on their own since it does not require a doctor’s prescription. The pharmacist is a qualified person, and he knows what to give to the customer. I am not totally against this decision, but at this stage, I am a bit sceptical about it. Even in the US, paracetamol and anti-allergic tablets are available at the grocery shop, but we cannot compare India with US, because people are less educated here and have no knowledge of the medicines," Dr. Chatterjee said, calling for a structured regulation.

The list as submitted by the sub-committee may be considered initially, which will be dynamic and updated from time to time, the DTAB minutes said. The board also recommended a comprehensive revisit of the draft notification, for which international guidelines may also be considered and directed the sub-committee to submit a report on it.

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Some of the OTC drugs that could go on retail shelves include Chlorohexidine Gluconate 0.2% (for the treatment of gingivitis), paracetamol tabs 500 mg (antipyretic), sodium chloride nasal spray, ketoconazole shampoo (anti-dandruff), lactulose solution (laxative), calamine lotion (anti-septic), xylometazoline hydrochloride (nasal decongestant) and bisacodyl tablets 5mg (laxative).