All India Organisation of Chemists & Druggists (AIOCD) has opposed the Union health ministry's proposal to put in place electronic platform for regulating sale of drugs in India saying that the proposed initiative is irrational and impractical in the wake of inadequate IT infrastructure in the country making it difficult for stockists and chemists to upload drug sale data on the e-platform.

Suresh Gupta, general secretary, AIOCD said “Its infeasible for retailers and stockists in remote and rural areas having limited or no internet connection to upload data related to every drug received, sold, returned to manufacturers by using mobile phones. A stockist sells more than 60,000-70,000 drug brands and deals with several retailers. Its not possible for him to upload data of every brand received, sold to retailers. It is also not feasible for retailers to upload every prescription on the portal and pay 1% of total cost of medicine subject to ceiling of Rs.200 per prescription in the country where IT infrastructure is inadequate.”

“We welcome government's initiative to come up with a mechanism to rein in spurious drugs menace but the recent initiative does not augur well for us,” he added.

There is a regulatory mechanism to keep record of drugs manufactured in the country and supplied it to stockists and retailers. There may be some issues pertaining to sale of drugs by retailers to consumers but there is local FDA to look into it, he said.

We are soon going to convene meeting of state office bearers of AIOCD to discuss the issue. Following this, office bearers of our district, state units will write to the health ministry opposing the proposal, said Gupta.

Health ministry on March 16 issued a notification regarding regulation of sale of drugs in the country. The circular proposed to set up e-platform wherein all manufacturers are required to register themselves and enter data relating to sale of drugs on the portal to stockists/wholesalers with batch number, quantity supplied and expiry date of the batch. All stockists/wholesalers will also be required to register themselves on the portal and enter details of stocks received and supplied by them to retailers. The data can be entered both through online and by using mobile phones. The pharmacies located in rural and remote areas can upload the data through mobile phones or internet once every fortnight. No retailer/chemist/e-pharmacist outlet shall be permitted to sell any medicine/drug unless such pharmacy is registered on the e-portal. The chemists or e-pharmacies will be required to enter details of drugs received, sold, returned to manufacturers. Schedule H, H1, X drugs can not be sold without prescription.

The details of medicines dispensed will be entered in the e-platform and bills will be generated through the system. Such details will include prescribing doctor’s registration number (MCI or State Medical Council or the Dental Council of India) or other authorised person’s identity number, the name and registration number of the dispensing chemist and the quantity supplied, etc in case of schedule drug. The patients' details will be available only to central and state drug regulators who can use data on the e-portal for the pharmacovigilance programme.

Pharmacies/e-pharmacies need to pay 1% of the total cost of medicines subject to a ceiling of Rs.200 per prescription. A small amount of registration fee and renewal fee as may be determined by the government from time to time shall also be payable by manufacturers/ pharmacies/hospitals/ clinical establishments, etc.

The exercise is part of the government initiative to amend regulation pertaining to sale of drug under Drugs and Cosmetics Act, 1940 to ensure supply of quality drugs thereby curbing anti-microbial resistance as well as regulate supply of medicines through internet to persons or other entities abroad.