Madras HC Restrains Online Sale Of Medicines Till Rules Are Notified [Read Order]

“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 cosmetic,”

The Madras High Court has restrained online business in drugs and cosmetics until Central Rules in this regard are notified.

Justice Pushpa Sathyanarayana directed the Central Government to notify the rules at the earliest, not later than 31^st January 2019.

“Unless the legislation keeps pace with the technology, the commerce based on technology has to lag behind”, the court said.

The court was considering plea by Tamil Nadu Chemists and Druggists Association seeking to block the link of all such websites from India, who are doing on-line sale of Schedule H, H1 and Schedule X medicines in violation of Rules 65 and 97 of the Drugs and Cosmetics Rules, 1945 till the licenses are granted to sell medicines through on-line.

Risks of online medical store

The court noted that there are several risks which are unique to online trading. It said:
“A patient receives a prescription drug based on on-line questionnaire instead of a valid prescription, which may result in serious side effects and this may be the most common risk without any regulation. The on-line selling of medicines does not require valid prescription, even when selling the prescription drugs. Secondly, the chance of the prescription drugs is delivered without any information to the patients. Yet another risk is that the patient may receive the counterfeit drugs, which are sub-standard or super-potent or adulterated. Counterfeit drugs are manufactured in packages and distributed without regulatory oversight and control exercised over genuine drugs. The important and major risk of purchasing drugs from an on-line store is the misuse of medical, financial and electronic information of patients. “

Proposed Rules

The court also took note of the proposed rules which are yet to be notified. It observed: “Rule 67-I of the proposed rules contains definition clauses defining 'e-pharmacy', 'e-pharmacy portal', 'Central Licensing Authority', ' prescription' and 'sale by way of e-pharmacy'. Rule 67-J mandates the registration of e-pharmacy, while Rules 67-L and 67-M specify the application for registration and conditions of registration respectively. According to Rule 67-Q, the registration issued to any person shall remain valid for a period of three years, which can be renewed under Rule 67-R. Rule 67-N provides for granting registration. Rule 67-K speaks about the disclosure of information generated through e-pharmacy portal. Rule 67-O empowers the Central Licensing Authority to depute officers for periodic inspection. Rule 67-P lays down procedure for distribution or sale of drugs through e-Pharmacy. Prohibition of advertisement of drugs is imposed under Rule 67-S. Rule 67-T empowers the Central Licensing Authority to suspend or cancel the registration with provisions to appeal and deemed cancellation. Rule 67-U and 67-V deal with complaint redressal mechanism and monitoring of e-Pharmacies. These provisions are intended to regulate the on-line trade of drugs and cosmetics and to prevent abuse of drugs.”

The court further observed: “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.. 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.”