The Centre has proposed an e-platform to track and regulate sale of online medicines and to curb antimicrobial resistance by making it mandatory for all manufacturers and retailers to register and document their sales.
Under the proposal, hospitals and other clinical establishments both in the public sector and private sector, will be required to enter details of medicines issued to patients while they will also be required to give details of any adverse reaction.
"The Health Ministry proposes to establish a robust e-enabled structure for regulating sale of medicines in the country. An electronic platform will be developed for regulating sale of drugs in the country," a public notice put up on the Health Ministry's website said.
The Ministry has asked for comments and suggestions from various stakeholders within 30 days.
"The objective of such regulation would be to ensure availability of right drugs that meet the standards of quality to every person in need of medicines, curbing anti-microbial resistance (AMR) and also regulating supply of medicines through online or internet to persons or other entities outside India," it said.
Under the proposal, all manufacturers will be required to register themselves and enter data relating to sale of drugs on the e-platform to different distributors - stockists, wholesalers and others with batch number, quantity supplied and expiry date of the batch.
At the same time, all stockists and wholesalers will also be required to register themselves and enter details of stocks received and supplied to them. The data can be entered both through online and by using mobile phones and for pharmacies located in rural and remote areas, the latter can do so through mobile phones or internet at least once every fortnight.
"No retailer, chemist or e-pharmacist outlet shall be permitted to sell any medicine or drug unless such pharmacy is registered on the e-portal," the proposed regulation said.
The proposal said that medicines other than drugs included in Schedule H, H1 and X will be dispensed or made available to any person only against prescription of a registered medical practitioner.
"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," it said.
After the rules come into force, it will be mandatory for all new pharmacies to register with Central Drugs Standard Control Organization (CDSCO) on payment of a fee. Existing pharmacies will get a transition period of two years for registration with the online portal, the proposal said.
"A system of audit by regulators for ensuring compliance with the Drugs and Cosmetics Act, 1940 and Rules will be developed. The audit will be facilitated through offsite analysis. No export of anti-bacterial or any habit forming drug shall be permitted against internet orders," it said.