Thursday, December 20, 2018

Madras High Court bans online sale of medicine till central government notifies regulatory rules

Dr KK Aggarwal & Advocate Ira Gupta

In the matter titled as “The Tamil Nadu Chemists and Druggists Association versus Union of India & Others” the Hon’ble Madras High Court has banned the online sale of drugs and cosmetics till the Central Government notified the proposed Drugs and Cosmetics Amendment Rules, 2018. The Hon’ble High Court has also directed the Central Government to notify the proposed Drugs and Cosmetics Amendment Rules, 2018 which deals with regulations and rules w.r.t. online sale of drugs and cosmetics, by 31stJanuary, 2019 and not later than that.

The judgment of the Hon’ble High Court of Madras is reproduced hereunder:

34. In this case also, though there is a statute, the regulatory rules are yet to be notified, in the wake of advancement of technology. Unless the legislation keeps pace with the technology, the commerce based on technology has to lag behind.

35. While the draft rules are published in the Gazette, they are yet to be notified. Once it is notified, there is bound to be disagreement between law makers, drug companies, on-line traders and finally the consumers. In the absence of any Central or State Government legislation or rules, on-line sale of prescription drugs could hardly be curbed.

36. The Central Government had already been given a longer rope by the order of the Division Bench, which was passed as early as on 20.12.2016. Though around two years have passed from the date of the said judgment, the rules are still at the draft stage.

37. For the reasons set hitherto, it becomes necessary for the Central Government to notify the rules at the earliest in the interest of public and the on-line drug trade. Accordingly, respondents 1 and 3 are directed to notify the proposed Drugs and Cosmetics Amendment Rules, 2018 in the Gazette at the earliest, however, not later than 31.01.2019. Thereafter, the concerned stakeholders, namely, persons doing trade in on-line pharmacy have to obtain their licences in the manner prescribed in the rules to be notified, within a period of two months from the date of such notification.

38. As the draft rules are framed by the Central Government, after deliberations including the stakeholders, till the aforesaid rules are notified, the on-line traders are bound not to proceed with their on-line business in drugs and cosmetics."

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

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