New Delhi: In a move that could save patients the bother of having to visit their doctor for every common ailment, the Central Drugs Standard Control Organization (CDSCO), the regulatory body for pharmaceuticals and medical devices, is considering introducing provisions in the Drugs and Cosmetics rules to allow pharmacists to dispense drugs for minor conditions and adjust dosages without a doctors’ prescription.
The drug regulator has proposed the introduction of a new category of over the counter (OTC) medicines consisting of anti-allergies, antipyretic (for fever), antiemetic (for vomiting and nausea), muscle relaxants, decongestants (for cough and cold), anti-inflammatory drugs, antacids, external preparations for skin and hormonal contraceptives, which pharmacists will be empowered to dispense without a doctor’s prescription.
The proposed provision, which is expected to shorten waiting periods at clinics, will be discussed at the drugs consultative committee (DCC) meeting on Monday. Chaired by the Drug Controller General of India (DCGI), the DCC meeting will be attended by state drug controllers from all across India.
According to the DCC agenda, reviewed by Mint, a special provision to include OTC medicines in the Drugs and Cosmetics rules has been proposed. If approved by DCC, the matter will be taken up by the government’s chief advisory body on drugs—the Drugs Technical Advisory Board (DTAB)—next month and will then be sent to the Union health ministry for final notification.
Over-the-counter drugs are common in many countries. Currently, in India allopathic drugs which are safe to be dispensed mostly fall under Schedule H and H1 and require a prescription. “As per D&C Act 1940 and thereunder Rules 1945, these drugs should be sold against prescription only. The new proposal therefore will make it easier for people to get these drugs hassle free," said a senior official, privy to the development requesting anonymity.
Officials at the drug controller office have already shortlisted OTC medicines to be put under a separate schedule which can be dispensed without a prescription. There are some restrictions though— pharmacists will not be allowed to prescribe habit-forming drugs or strong antibiotics.
Kailash Gupta, president, All India Chemists and Distributors Federation, said that the expanded powers will have several advantages, “including increased convenience and accessibility for those who need refills or have a minor condition. The patients will be able to cut down on doctors consultations fees and the improved ability of the pharmacist to help manage a patient’s long-term care will help alleviate pressure on hospital emergency rooms and doctor’s offices."
“Other benefits include the ability of pharmacists to prescribe drugs in times of emergency and assist patients who don’t have a family doctor," he added.
Officials believe that the move will boost Prime Minister Narendra Modi’s vision of improving accessibility and affordability of drugs. “Pharmacists play a crucial role in the healthcare system due to their easy accessibility. International practices show that there is a separate category of drugs which are harmless and safe enough to be dispensed without any prescription. We want to bring this concept in India too which will help people skip doctor’s visit for common ailments. This will make access to drugs easier for not only those living in urban areas but those living in rural areas and mostly dependent on quacks. The pharmacists are qualified to provide these services and have been underutilized," said the official cited above.
Doctors, however, raised questions over potential conflict of interests because the pharmacists would be both prescribing and selling drugs.
“The process of prescription of medications requires long years of learning. A pharmacist does not know the microbiology, physiology and medical history of a patient as well as the full potential of a certain drug. Thus, by prescribing, not only will he be causing harm but also adding on further problems to a patient," said Rahul Pandit, director, intensive care, Fortis Hospital, Mulund, Mumbai.
According to figures available with the Union health ministry, currently, India ranks 11th in the global OTC market size. Revenue from OTC medicines in India makes up 21% of the total market revenue of $20 billion.