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IN THE HIGH COURT OF JUDICATURE AT MADRAS
PUSHPA SATHYANARAYANA, J.
The Tamil Nadu Chemists and Druggists Association, Rep by its General Secretary, Mr. K.K. Selvan - Petitioner
Versus
The Union of India, Through the Department of Health and Family Welfare & Ors. - Respondents.
W.P.No.28716 of 2018 and W.M.P.No.33542 of 2018
Decided On : 17-12-2018
Drugs and Cosmetics Act, 1940 - Section 18 - Constitution of India - Article 226 - challenges to the State and Central Governments - sale of certain drugs and cosmetics - statute demands that with the advance in science and technology - What cannot be permitted can be regulated ? This seems to be the Mantra of the Central and State Governments. But the rapid growth of e-commerce continues to present challenges to the State and Central Governments in the trade of on-line pharmacy. The protests made, when Amazon, Flipkart and Snapdeal, entered in general retail, are being continued in retail medicine. The Central Government continues to lag in passing a specific legislation aimed at the On-line pharmacy industry – Held, 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 - 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 - 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 - 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 - Section 20 operates in one field, namely, conferring a power of entry on the licensee. The said provision empowers the licensee inter alia to alter a meter which would include replacement of a meter. It is an independent general provision. In absence of any statutory provision, we do not see any reason to put a restrictive meaning thereto. Even under the General Clauses Act, a statutory authority while exercising statutory power may do all things which are necessary for giving effect thereto. There does not exist any provision in any of the statutes referred to hereinbefore which precludes or prohibits the licensee to replace one set of meter by another - petition disposed of
ORDER :
Prayer : Writ petition filed under Article 226 of the Constitution of India praying for a Writ of Mandamus directing the respondents to block the link of all such websites, who are carrying on online 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 licences are granted to sell medicines through online.
What cannot be permitted can be regulated ? This seems to be the Mantra of the Central and State Governments. But the rapid growth of e-commerce continues to present challenges to the State and Central Governments in the trade of on-line pharmacy. The protests made, when Amazon, Flipkart and Snapdeal, entered in general retail, are being continued in retail medicine. The Central Government continues to lag in passing a specific legislation aimed at the On-line pharmacy industry.
2. The petitioner is an Association of the Tamilnadu Chemists and Druggists, represented by its General Secretary and the Writ Petition has been filed for blocking 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 (in short "D & C Rules"), till the licenses are granted to sell medicines through on-line.
3. At the outset, there was a preliminary objection raised by the respondents contending that the Writ Petition is barred by the principles of res judicata. Earlier, the very same petitioner had filed W.P.No.28325 of 2016 for an identical prayer directing the respondents to block the link of all such websites from India who are selling the on-line medicines. The said Writ Petition was taken up along with another Writ Petition No.5611 of 2016, which was filed for banning of such websites from selling Schedule H medicines in violation of the D and C Rules and the following common order was passed on 20.12.2016 by a Division Bench of this Court :
“It is stated that the Sub-Committee constituted by the Drugs Consultative Committee (DCC) to examine the issue relating to the sale of drugs over the internet has submitted its report to the DCC, which, in turn, in its 50th meeting held on 4th and 5th November, 2016, has accepted the report and the same has been forwarded to Ministry of Health and Family Welfare for consideration.
2. Learned Assistant Solicitor General states that thereafter it may be put in public domain whereafter final decision will be taken. The process may require about three (3) months.
3. The aforesaid submission is taken on record. No further directions are required in the matter.
4. Writ Petitions are, accordingly, closed. Consequently, W.M.P.No.24439 of 2016 also stands closed.
5. List for compliance on 24.03.2017."
4. The above Writ Petitions were closed on the undertaking given by the Central Government/first respondent therein that the Rules will be published in the public domain within a period of three months. Albeit, only the draft Rules have been published as on date.
5. The contention of the petitioner is that the Central Government has not passed the rules and regulations, but the respondents continue to sell the medicines through on-line. Therefore, permitting sale of drugs through Internet/on-line defeats the purpose of the provisions of the Drugs and Cosmetics Act, 1940 (in short "D & C Act") and the D & C Rules framed thereunder to safeguard the public interest, which regulates the manufacture and sale to ensure quality and availability under prescribed storage conditions by qualified pharmacists. It is averred in the petition that there are provisions under the D & C Act for recalling drugs due to very serious side-effects from the market and this would be possible only if the medicines are sold by the pharmacists, who are aware of the movement of the medicines till it reaches the patients. There is no guarantee for data privacy if the medicines are sold on-line. Disease and treatment are the private information of the
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