India’s Ministry of Health and Family Welfare has mooted the idea of an electronic platform for regulating the sale of medicines in India, and has begun a public consultation to accept comments regarding this proposal. Comments may be sent to firstname.lastname@example.org before the 15th of April 2017. A brief summary of the proposal:
1. The portal: An online platform for regulating the sale of drugs in India will be developed, which will be maintained by an autonomous body under the Ministry of Health and Family Welfare. The revenue model proposed for this portal involves a small transaction fee of not more than 1% of total cost of medicines, subject to a ceiling of Rs 200 per prescription, to be paid online by pharmacies/ e-pharmacies/ wholesale /retail distributions, etc.”, as well as a “small amount of registration fee and renewal fee for manufacturers/ pharmacies/hospitals/ clinical establishments, etc.”
2. Distributors and Manufacturers will have to register and upload data: All manufacturers and distributors will have to register themselves with the portal. Manufacturers will have to enter data relating to the sale of drugs to distributors with a batch number, quantity supplied and expiry date of the batch, while distributors will have to enter details of stocks received and supplied by them to other distributors or retailers.
3. Retailers/pharmacists will have to register and upload data: It will be mandatory for all new pharmacies to register and pay a fee. Existing pharmacies will get a transition period of two years for registration with the online portal. Such existing pharmacies which register within first six months will be required to pay 60% of the fee prescribed for such registration.
Pharmacies in rural or remote areas can upload the data at least once a fortnight. Only retailers who are registered with the portal will be allowed to sell medicine. They’ll have to provide data on medicines/drugs received, sold, returned to the manufacturer or disposed of in any other manner.
– For offline pharmacies – No dispensing/sale of drugs shall be permitted by any entity beyond the area for which a licence has been granted.
– For E-pharmacies – “No sale by e-pharmacy shall be permitted to be carried out by any person or entity unless, it has a licenced brick and mortar facility in each of the Licencing Authority’s jurisdiction.” Also, “No export of anti-bacterial or any habit forming drug shall be permitted against internet orders”, and “Any person or entity proposing to export other medicines/drugs on the basis of internet orders shall be required to be registered with the CDSCO and details of such registration will need to be mentioned in the invoice when exporting such medicines/drugs.”
5. Prescriptions: “Medicines other than drugs included in Schedule H, H1 and X will be dispensed or made available/distributed to any person only against a prescription of a registered medical practitioner. However, in the case of a few identified medicines, any other person specifically authorized (such as ASHA) to distribute a particular class of medicines may do so.”
6. Tracking medicine sales: details of medicines dispensed, including “prescribing doctor’s registration number or other authorized person’s identity number, the name and registration number of the dispensing chemist and the quantity supplied, etc” will be entered in the e-platform and bills will be generated through the system.
7. Patient data: “Details of other than the patient name and identity shall not be necessary in case of drugs not included in Schedule H, H-I or X.” The details of patient authorised person, etc. shall be kept confidential and shall not be disclosed to anyone other than the Central and State Drug Regulators or other officers authorised by the Central or State Governments. The details could, after removing the confidential information, be also made available to the Pharmacovigilance Programme of India (PvPI).”
8. Auditing of data: “At the backend, a system of audit by regulators for ensuring compliance with the Drugs and Cosmetics Act, 1940 and Rules thereunder will be developed. The audit will be facilitated through offsite analysis.”
This process does a couple of things: it legitimises online pharmacies in India, which have been operating in a grey area, in the absence of a regulatory regime, and puts them on a level playing field with offline pharmacies. The requirement to have a physical pharmacy in each license area seems onerous, because it then adds an additional unnecessary cost to the operations of online pharmacies. The tracking of medicines is important, from the manufacturer to the pharmacy, because that helps address sale of medicines without adequate monitoring. It’s also quite comforting that the Ministry of Health hasn’t asked for Aadhaar authentication for purchase of medicines, though I wouldn’t put it beyond the current regime to do that eventually.
Reminder that the last date for filing comments is the 15th of April 2017, and the email address is email@example.com