Following health ministry’s proposal to set up an e-platform to regulate sale of medicines in the country, drug retailers have argued that electronic registration platform imposes undue scrutiny to drug retailers and wholesalers without rendering accountability to doctors who prescribe medicines quite often without maintaining patient records.
As per the proposed plan, all the manufacturers, stockists and retailers will be required to register themselves on the e-portal and enter data related to sale of drugs with batch number, quantity and expiry date. The data can be entered online through mobile phones also as per the government’s notice.
As per the notice, no retailer or e-pharmacy shall be permitted to sell any medicine/ drug unless it is registered with the e-portal. They are supposed to enter all the details of medicines and drugs sold, returned to the manufacturer or disposed in any manner.
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.
The notice further states that no dispensing/sale of drugs shall be permitted by any entity beyond the area for which a licence has been granted. Medicines other than drugs included in Schedule H, H1 and X will be dispensed or made available/distributed to any person only against prescription of a registered medical practitioner. However, in case of a few identified medicines, any other person specifically authorised (such as ASHA) to distribute a particular class of medicines may do so.
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.
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 or authorised person 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).
Hospitals and other clinical establishments or other authorised persons, both in the public sector and the private sector, shall be required to enter details of medicines dispensed or distributed/issued/made available to patients as also details of any adverse reaction, etc. and such data shall be kept confidential and made available only to PvPI and the regulator in the manner specified above.
At the backend, a system of audit by regulators for ensuring compliance with the Drugs and Cosmetics Act, 1940 and Rules there under will be developed. The audit will be facilitated through offsite analysis.
The information collected may also be used by the Ministry of Health and Family Welfare, Government of India for such purposes as considered necessary in public interest.