Govt plans to frame regulations for over-the-counter drugs to control abuse

Govt might ask chemists to stamp prescriptions to avoid misuse

The Central Drugs Standard Control Organisation (CDSCO) plans to frame  regulations for non-prescription drugs, or over-the-counter (OTC) drugs. The drug safety controller plans to do this in order to make rules clearer on which drugs can be sold without a doctor’s prescription.

G N Singh, Drug Controller General of India (DCGI), told Business Standard, “Currently there can be misuse of high-risk drugs as there are no separate regulations. Names of drugs that cannot be sold over the counter are not there. At present, drugs classified as Schedule X, H, H1, G and K cannot be sold without a doctor’s prescription.” The government is also planning to take this further by asking chemists to stamp prescriptions so that prescriptions are not reused.

The new guidelines for over-the-counter products come in an attempt to reduce anti-microbial resistance due to overconsumption of these drugs. The drug controller is also doing this to fall in line with international practices, which have separate rules for OTC products. The government will do this by amending the Drugs and Cosmetics Rules.

A particular drug can make it to the OTC category from prescription drug if the drug controller feels it is of low risk. Should the drug be proven high-risk at any point in time, the drug controller can make it a prescription drug.

A committee set up by the drug consultative committee will consider reclassifying certain drugs which are at present in Schedules X, H, H1 , G and K. Drugs in these categories are considered high-risk and are for diseases such as cancer.

The All India Chemists and Druggists Federation (AICDF) is of the opinion that the government should cap the margins on over the counter products and ensure a minimum margin on such products.  

Domestic pharmaceutical companies are now focusing on the over-the-counter segment to accelerate sales growth. They are relaunching older prescription brands in the space or taking an inorganic route to beat the slowdown in sales. The industry’s domestic pharmaceutical sales growth dipped to 5.5 per cent in 2017 — the lowest rate in eight years.

Relaunching older prescription drugs in the OTC space allows companies to overcome sluggish prescription growth and also extend the life of mature brands. Pegged at over $2.7 billion (Rs 188.6 billion) as of 2016, according to the Nicholas Hall 2017 report, the Indian OTC market is expected to grow at a CAGR of 9 per cent to cross the $6.5-billion (Rs 441.1 billion) mark by 2026.