The Indian Drug Manufacturers' Association (IDMA) has demanded revocation of provision related to requirement of brick and mortar facility for e-pharmacy to carry out operation, stipulation of prescription for sale of drugs other than included in schedule H, H1, X and no sale of drugs by any entity beyond jurisdiction of licensing authority proposed in the health ministry's draft notification on regulation of sale of drugs in the country.
In a memorandum submitted to Deputy Secretary (Drug Regulation), Ministry of Health and Family Welfare, IDMA said that provision (xi) in the circular which says no sale by e-pharmacy shall be permitted to be carried out by any person or entity unless, if it has no licensed brick and mortar facility in each of the Licensing Authority’s jurisdiction needs to be omitted.
As regards provision (xii) stating that no dispensing/sale of drugs shall be permitted by any entity beyond the area for which a licence has been granted, the industry body said that under existing Drugs and Cosmetics Act, 1940 and Rules, 1945, the licenses are granted to the premises and any specific jurisdiction or area of operation is not defined under the license. If this requirement is incorporated then it will impose prohibition on sale and distribution beyond a particular area. As a result, the manufacturers, distributors and wholesalers will not be allowed to sell and distribute drugs to different places in the country as is done today on the strength of single license granted under the Act.
The provision (xiii) which says 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, is inconsistent with the existing provisions of Rule 65. Under the Rule 65(9) prescription is required only for drugs included in Schedule H, H1 and X. If this point is included then every drug will have to be sold on the prescription of the Registered Medical Practitioner, said Deepnath Roy Chowdhury, national president, IDMA.
The notification proposed that all the drug manufacturers, wholesalers and retailers will be required to register themselves on the e-platform and enter data pertaining to sale of medicines with batch number, quantity and expiry date. The data can be entered through both online and by using mobile phones.
Chowdhury said that since the portal will be in the public domain there will be issues of data integrity. We are concerned about the confidentiality of such data. The system has to be fool-proof so that such data about the products manufactured do not go to the wrong hands.
The Modi government has been encouraging ‘ease of doing business’. On the contrary, proposals mentioned above appear to be against ease of doing business, he added.
The government needs to examine these issues from the perspective of logistics and capacity building especially with the SME sector and the trade channel i.e. distributors, wholesalers and retailers. Otherwise it may lead to complications including availability of medicines at the time and place of requirement, he concluded.