Two years after a proposal was first being considered, India will soon see a definition and regulations for over-the-counter (OTC) drugs. OTC drugs are those that can be brought by the customer directly, as opposed to prescribed medicines, which cannot be bought without a prescription from a doctor. Basic medicines like antacids, cough syrups, balms and certain ointments usually do not require a prescription in India.
However, this comes with risks. Sanjeev Singh, the president of the Telangana wing of the Indian Medical Association told TNM while some medicines can be sold without a prescription, some medicines that require a prescription are being without one currently. These are medicines that may cause side-effects, but since they are not prescribed by a practicing doctor, the consumers or patients may not know about it.
Need for proper definition, regulation
At present, there is no set definition for what constitutes an over-the-counter drug, and India’s laws have no mention of it. Drugs in India are labelled under different schedules. In 2013, the Union government, under the Drugs and Cosmetics Rules, stated that drugs that are categorised under Schedule H, H1 and Schedule X specifically need a prescription. However, all other medicines do not necessarily need a prescription.
According to Sanjeev Singh, indiscriminate consumption of OTC drugs without a proper regulation will also lead to medicine resistance.
Another issue, Singh says, is that different companies name their drugs differently. “It is always better if the prescription given by doctors mentions the generic name of the medicine. If doctors want, they can include the company name as well but the generic name should be mentioned. This will cause fewer problems for the patient as well.”
What the government’s proposal states
As a solution to weed out the ambiguity, the Drugs Consultative Committee under the Health Ministry’s Central Drugs Standard Control Organization has recommended a proper definition and regulation for these drugs. The government committee suggested that the distribution and sale of medicines be regulated and a draft be prepared for necessary amendments to the Drugs and Cosmetics Rules.
In addition to identifying and labelling the drugs as OTC, the committee also suggested that the medicines be classified into OTC-1 and OTC-2, based on the extent of evidence of safety, therapeutic index (the ratio between the largest dose producing no toxic symptoms and the smallest dose routinely producing cures), need for accessibility to patients, availability, non-habit forming nature, present supply chain mechanism and socio-economic condition of the country.
Along with the regulation of sale and even approvals of the OTC drugs, the committee has also recommended that advertisements of the drugs be regulated.
Singh says that the regulations must be stringent.
“There are some over-the-counter drugs that can be sold without any issue but the thing is, pharmaceutical companies are making advertisements for all sorts of drugs, irrespective of doctor consultation. Recently, there was an ad for cremaffin, a laxative, which has been advertised in such a way that it can be taken without any doctors' consultation. In fact, it can cause a lot of gastric problems like diarrhoea,” Singh says.