Soon, you may get more drugs over the counter
NEWDELHI: In a move that could save patients the bother of having to visit their doctor for every common ailment, the Central Drugs Standard Control Organisation (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) drugs consisting of anti allergies, antipyretic (for fever), antiemetic (for vomiting and Nausea), muscle relaxants, decongestants (for cough and cold), antiinflammatory drugs, antacids, external preparations for skin and hormonal contraceptiveswhich 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 drugs in the Drugs and Cosmetics rules has been proposed. If approved by the DCC on Monday, the matter will be taken up by the government’s chief advisory body on drugs — the Drugs Technical Advisory Board — next month and will then be sent to the 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 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 shortlisted OTC drugs 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 accessibility for those who need refills or have a minor condition.”
Doctors, however, question the move. “A pharmacist does not know the full potential of a certain drug. So by prescribing he is likely to cause further problems to a patient,” said Dr Rahul Pandit, director, Intensive Care, Fortis Hospital, Mulund, Mumbai.