Registration on e-portal mandatory for manufacturers, distributors and retailers

Mumbai: Manufacturers, distributors and retailers interested in selling drugs and medicines online will have to register themselves on an e-portal, to be set up soon by the Centre, the State government told the Bombay High Court on Thursday to convey the proposed measures to regulate online sale of medicines.

A Division Bench comprising Chief Justice Manjula Chellur and Justice N.M. Jamdar was hearing a PIL filed by Mayuri Patil that said several Schedule H drugs and those not approved by the Food and Drug Administration (FDA) are being advertised and sold online without following the provisions of the Drugs and Cosmetics Act. It also said students were buying drugs online using fake medical prescriptions.

On September 20, 2016, the court had directed the State government to get in touch with Information and Broadcasting and Information Technology departments on steps they propose to take, and stop the advertisement of sale of drugs online and on television. An affidavit was filed by the Assistant Commissioner, FDA in the form of an action-taken report with respect to the sale of drugs through the internet for violation of the provisions of Drugs and Cosmetics Act 1949 and Rules, 1945.

The affidavit said, “The Central government formulated a sub-committee under the Drugs Consultative Committee of Drugs and Cosmetics Act 1940 under the chairmanship of the then Commissioner, FDA, to examine the issue of regulating sale of drugs (medicine) over internet under the Drugs and Cosmetic Rules. The sub-committee then submitted a report to the central government in September 2016. Pursuant to this, the Ministry of Health and Family Welfare Department of Health has issued a public notice for public consultation regarding regulation of sale of drugs in the country.”

Additional government pleader P.P. Kakade told the court that a public notice had been issued by the Union Ministry of Health and Family Welfare in March this year on the need to plug the gaps in sale of drugs, including their online sale. “The objective of such a 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 online or over the internet to persons or other entities outside India,” the notice said.

“The government proposes to establish a robust e-enabled structure for regulating the sale of medicines. An electronic platform will be developed and maintained by an autonomous body under the Ministry of Health and Family Welfare,” the notice said. It said all wholesalers and distributors will also be required to register themselves on the portal and enter details of stocks received and supplied by them to further distributors or retailers. No retailer, chemist and e-pharmacist outlet shall be permitted to sell any medicine or drug unless registered on the portal. The pharmacy outlets will also be required to enter details of all medicines or drugs received, sold, returned to the manufacturer or disposed of in any other manner.

Medicines included in Schedules H, H1 and X of the Act shall be dispensed or sold only on a medical practitioner’s prescription. Details including the prescribing doctor’s registration number, name and registration number of the chemist and the quantity supplied will be entered on the e-platform and bills will be generated through the system.

An initial grant and minimum human resources will be provided by the Ministry of Health and Family Welfare to the identified autonomous body, and expenditure incurred on this count will be met from the Consolidated Fund of India for an initial period of two years.

“The data can be entered both online and using mobile phones. The pharmacies located in rural and other remote areas can upload the data via mobile phones at least once every fortnight and much more,” the affidavit read.

Further hearing in the matter has been adjourned for eight weeks. — With PTI inputs