Govt plans to set up e-platform to regulate sale of drugs
Mumbai: An electronic platform that will track the movement of drugs from the manufacturer to the patient through the entire supply chain may become a reality, if a health ministry plan goes through.
The platform, pitched as an attempt to plug gaps in the distribution system, will be developed and maintained by an autonomous body under the health ministry. The health ministry has made the proposal as part of the draft regulations on the sale of drugs in the country that have been put up on the ministry’s website for public comments to be submitted by 15 April.
All manufacturers must be registered on the portal and enter data relating to sale of drugs to distributors with the batch number, quantity supplied and expiry dates, according to the draft. All distributors (stockists, wholesalers, retailers and e-pharmacies) must also get registered and enter details of stocks received, supplied, sold and returned to the manufacturer, it said.
“No retailer/chemist/e-pharmacist outlet shall be permitted to sell any medicine/drug unless such pharmacy is registered on the e-portal,” the ministry of health and family welfare said in its draft norms.
Hospitals and other clinical establishments or other authorised persons, both in the public sector and the private sector, will also be required to enter details of medicines dispensed to patients and details of any adverse reaction. Such data will remain confidential.
The norms prescribe that medicines, other than approved over-the-counter products, will have to be sold only against prescription of a registered medical practitioner.
“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 or other authorised person’s identity number, the name and registration number of the dispensing chemist and the quantity supplied,” the health ministry proposed.
Details of the patient’s name and identity will also have to be entered, but these details will not be disclosed to anyone other than the central and state drug regulators or other officers authorised by the central or state governments.
The proposed regulation stipulates that e-pharmacies will not be permitted to sell drugs unless they have a licensed physical facility in each of the licensing authority’s jurisdiction. Export of anti-bacterial or any habit-forming drug will not be permitted against internet orders.
At the back-end, a system of audit by regulators will be developed for ensuring compliance with the Drugs and Cosmetics Act, 1940 and Rules.
With effect from the date the new rules come into force, it will be mandatory for all new pharmacies to register with the Central Drugs Standard Control Organization and existing pharmacies will get a transition period of two years for registration with the online portal.
The health ministry has held preliminary discussions with stakeholders to come up with ways and means to regulate sale of drugs, including online sales, in an efficient manner.
“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 and also regulating supply of medicines through online/internet to persons or other entities in outside India,” the ministry said.