The center offers the sale without a prescription of paracetamol and 15 other drugs


A large number of drugs in the country are readily available in pharmacies without a doctor’s prescription, but Indian drug laws do not define over-the-counter drugs.

Representative image. News18

The Union government, for the first time, has proposed to introduce over-the-counter (OTC) drugs in India through an amendment to the Drugs and Cosmetics Rules and allow their sale on the retail market without a medical prescription.

A draft notification issued by the Union Health Department proposed that the 16 drugs, which include common antipyretic drugs such as paracetamol 500mg, certain laxatives, nasal decongestants and topical antifungal creams, be included in the category of over-the-counter drugs.

The ministry requested public comments on the draft amendment within a month.

A large number of drugs in the country are readily available in pharmacies without a doctor’s prescription, but Indian drug laws do not define over-the-counter drugs.

Ministry officials said Money control that earlier this year, the Drugs Technical Advisory Board (DTAB), the government’s main drug advisory body, approved the new OTC policy.

“After that, there was an in-depth discussion about the drugs approved for the category and to start with, 16 drugs are expected to be licensed as over-the-counter drugs in the country,” an official said. “Later, we will expand this category further and add more drugs to the OTC list.”

Conditions

The conditions mentioned in the draft notification state that the specified drugs may be sold at retail without a prescription from a licensed physician only if the maximum duration of treatment or use does not exceed five days and the symptoms do not resolve, patients consult a doctor.

Another condition states that the size of the medicine package must not exceed the maximum recommended dose for five days and each package is accompanied by a patient information leaflet.

In addition, the claimed indication must be the same as that already approved by the licensing authority for each drug, the draft also specifies.

No OTC policy currently

Chinu Srinivasan, a drug and pharmaceutical expert from All India Drug Action Network – a patient advocacy organization – pointed out that over-the-counter drugs are not defined by either the Drugs and Cosmetics Act 1940 or the Drugs and Cosmetics Rules 1945.

“Even the draft notification does not define what OTC means, does it not give a clear indication of the choice of criteria used to select certain drugs as OTC,” Srinivasan said, and expressed surprise that other routinely used drugs such as oral rehydration salt (ORS) are not included in the list.

Pointing out that the choice of 16 drugs offered for over-the-counter sale is inexplicable, he also said that drugs prescribed by Accredited Social Health Activists (ASHAs) should be on the OTC drug list.

“Furthermore, the purpose of having an OTC list is achieved if pharmacists selling prescription drugs are penalized by routine inspections and monitoring mechanisms,” Srinivasan said.

Read all Recent news, New trends, Cricket News, bollywood news,
India News and Entertainment News here. Follow us on Facebook, Twitter and Instagram.

Previous The scientific reason why running at night is so much harder
Next Mangaluru: St Aloysius ITI holds annual day program