The government is set to come up with a list of over-the-counter (OTC) medicines under a separate schedule by making changes in the drug law with stringent regulations on quality, advertisement and pricing of such products.
“The move is aimed at promoting self-care and reducing the cost of treatment without compromising patient safety. It will also help us ensure that ‘prescription-only’ drugs are not misused, while other commonly used medicines which are not toxic are easily available to patients,” a senior official told TOI.
The decision to have separate provision for OTC under the Drugs and Cosmetics Act was taken in a meeting of the Drugs Consultative Committee (DCC) under the health ministry last month. DCC’s decision is based on recommendations of a sub-committee formed earlier to examine the issue.
“The sub-committee is of the opinion that there is an urgent need for defining OTC drugs and to lay down specific provisions for the regulation of OTC drugs in the country,” the DCC noted in its minutes of the meeting.
The DCC has directed the sub-committee to identify such list of OTC products along with conditions and frame draft for amendments in the law.
At present, there is no definition of OTC medicines and therefore, any medicine that is not a ‘prescription-only’ product, automatically qualifies as OTC. Pharmacists are free to sell such products on their own and patients can buy them without any medical advice or consultation.
Commonly used analgesics like paracetamol and ibuprofen and medicines for cough, cold and flu fall under the OTC category.
Apart from the advertisement norms and definition, the proposed changes will include basic characteristics of OTC drugs and their classification into OTC-1 and OTC-2 based on safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, supply chain mechanism and socio-economic conditions of the country.
It will also define criteria and conditions for any medicine to switch from prescription drugs to OTC category as well as regulation for new OTC drug approval, distribution & sale.
Such OTC products can also be advertised, whereas advertisement of prescription drugs is prohibited under the law.
“In the absence of a clear definition and legal recognition to OTC products, it is difficult to regulate them. On one hand, these are pharmaceutical products or medicines and hence fall under the drug law. However, since many of them are not listed under Schedule H and X – which are for ‘prescription-only’ products – they circumvent the regulation,” an official said.
Companies often also tweak commonly used formulations to bring their popular products out of the prescription-only list and then sell such products as OTC under similar sounding brands. This also helps them circumvent price control at times as the changed combination is unlikely to be part of the price controlled National List of Essential Medicines (NLEM).
Similarly, newly launched products are often not part of the Schedule H and X, and companies or chemists are free to sell them as OTC without prescription till the time they are brought under the provisions of the law.
The government and the regulator are also concerned about chemists pushing some high-end antibiotics as OTC products, causing potential risk of antimicrobial resistance. – TOI