In a matter regarding sale of different types of medicines online in an unregulated manner, the Assistant Commissioner of Food and Drugs Administration has filed an affidavit before the bench of Chief Justice Manjula Chellur and Justice NM Jamdar.
According to a PIL filed by one Mayuri Patil, a professor, several schedule ‘H’ drugs as well as drugs which are not approved by the Food and Drug Administration (FDA) are being advertised and sold online as well as through the television, without following the Drugs and Cosmetics Act and the Rules and Regulations framed thereunder.
The Bombay High Court had directed the state government on September 20, 2016, to get in touch with the Information and Broadcasting Ministry and its various departments and propose methods in order to stop such sale of medicines.
The affidavit states that the Central government formed a sub-committee under the Drugs Consultative Committee of Drugs and Cosmetics Act 1940. The then Commissioner, FDA (Food and Drugs Administration), was appointed as the chairman of this sub-committee which would examine the issue of regulating sale of drugs/medicines online under the Drugs and Cosmetic Rules.
Thereafter, a report was submitted by the sub-committee to the Central government.
Subsequent to this, following course of action has been proposed by the Union Ministry of Health and Family Welfare:
(a) An electronic platform will be developed for regulating sale of drugs in the country.
(b) The e-platform will be developed and maintained by an autonomous body under the Ministry of Health and Family Welfare.
(c) An initial grant and minimum human resources will be provided by the Ministry of Health and Family Welfare to the identified autonomous body and the expenditure incurred on this count will be met from the Consolidated Fund of India for an initial period of two years.
(d)The autonomous body will generate its own resources for meeting all its operational requirements beyond two years.
(e) All manufacturers will be required to register themselves with the said portal and enter data relating to sale of drugs on the said e-platform to different distributors i.e., the stockists/ wholesalers or otherwise with batch number, quantity supplied and expiry date of the batch.
(f) All the stockists/ wholesalers or other distributors will also be required to register themselves on the said portal and enter details of stock received and supplied by them to further distributors and retailers.
(g)The data can be entered both through online and by using mobile phones.
(h) The pharmacies located in rural or remote areas can upload the data either through mobile phones or through internet at least once every fortnight.
(i) No retailer/chemist /pharmacist will be allowed to sell any medicine/drug unless such pharmacy is registered in the e-portal.
(j) The retailers, i.e., the chemists, druggists or e-pharmacy outlets will be required to enter all details of the medicine drugs received, sold, returned to the manufacturer or disposed off in any other manner.
Some of the other measures that were mentioned as part of the said proposal are:
(k) Hospitals and other clinical establishments or other authorised persons both in public sector and 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 will only be made available to the Pharmacovigilance Programme of India and the regulator.
(l) 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.
Additional government pleader PP Kakade informed the court that a public notice has been calling suggestions and objections to regulate the sale of drugs online and sought adjournment. This matter will now come up for hearing in eight weeks.