SEKAR REPORTER

The Tamil Nadu Chemists and Druggists Association, Chennai’ filed a Writ Petition in W.P.No.28716 of 2018, praying for the issuance of a Writ of Mandamus directing the respondents, to block the link of all such websites,

Sekar Reporter
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Notes on e-pharmacy case.

  1. Initially, “The Tamil Nadu Chemists and Druggists Association, Chennai’ filed a Writ Petition in W.P.No.28716 of 2018, praying for the issuance of 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 Cosmetic Rules, 1945, till the licences are granted to sell medicines through online.
  2. It was the case of the writ petitioner that online sale of medicines are done through more than 3500 websites which are dealing online medicines and distributing the same all over the country and the same is in violation of Rules 61 and 65 of the Drugs and Cosmetics Rules, 1945 and without valid permission/licence granted under the said rules, they cannot sell or dispense medicines through websites and unless the draft rules, namely the Drugs and Cosmetics (Amendment) Rules, 2018 is approved and notified, such kind of trade cannot be allowed to take place and since the administration of the drugs also concerns with health and lives of patients, such kind of trade activity can be undertaken only in accordance with law.
  3. The third respondent (Union of India/CDSCO) has filed a counter affidavit and took a stand that no medicines in the country can be sold without licence and if any person found selling medicines not licensed for the purpose of sale or exhibits for sale, shall be prosecuted under Section 27(b)(ii) of the Drugs and Cosmetics Act, 1940 and necessary communications have been sent to the State Drugs Controllers to keep a strict vigil on the online sale of medicines and take action against those indulging in online sale of medicines in violations of the provisions of the Drugs and Cosmetics Act and Rules framed thereunder. The said official also speaks about the 48th meeting of the Drugs Consultative Committee (DCC) held on 24.07.2015 and took a stand that illegal sale through Internet can only be restricted, if there exists an alternative provision and the said Committee has also been constituted to examine the issue relating to sale of drugs through Internet and the said Committee has also submitted a report and a public notice dated 16.03.2017 also came to be issued inviting comments from various stakeholders including the All India Organization of Chemists and Druggists Association and Indian Internet Pharmacy Association had also responded to the same and the Government of India, Ministry of Health and Family Welfare has also issued the draft amendment to the Drugs and Cosmetics Rules, 1945 for inclusion of the rules to regulate online sale of drugs, vide notification No.G.S.R.817(E) dated 28.08.2018 and the comments received are pending due consideration before the first respondent and for the reasons stated, prayed for the dismissal of the writ petition.
  4. After perusing the counter affidavits filed other respondents and after taking into consideration the materials placed, vide order dated 17.12.2018, the learned Single Judge, disposed of the writ petition W.P.No.28716 of 2018. The operative portion of the order is as follows;

“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.

  1. As the draft rules are framed by the Central Government, after deliberations including the stakeholders, till the aforesaid rules are notified, the online traders are bound not to proceed with their online business in drugs and cosmetics.”
  2. Aggrieved, several persons/companies carrying on online business, filed appeals in W.A.Nos.2807, 2808, 2809, 2810, 2814 and 2818 of 2018 and inter alia filed Civil Misc. Petitions, in CMP.Nos.23341, 23345, 23346, 23350, 23369 and 23435 of 2018 for interim relief.
  3. It is seen that a Counter Affidavit was filed by the Deputy Drugs Controller, South Zone, Chennai-6 and she took a stand that no medicine in the country can be sold without any licence and if any person found selling medicines from a premise not licenced for the purpose of sale or exhibits for sale, shall be prosecuted under Section 27(b)(ii) of the Drugs and Cosmetics Act and necessary instructions have also been given to all the State Drugs Controllers to keep a strict vigil on the online sale of medicines and to take action against those indulging in online sale of medicines in violation of the provisions of the Drugs and Cosmetics Act, 1940 and Rules framed thereunder.
  4. All the CMPs were heard by the Division Bench and after hearing the parties, the Division Bench of Hon’ble High Court has passed an Order on 2-1-2019 granting interim relief to the appellants/e-pharmacies. The operative portion of the Order dated 2-1-2019 is as follows;
    “24. Online sale is going on for quite some time and if all of a sudden it is stopped till the amendments are notified, it would definitely create grave hardship, inconvenience and health issues to the concerned patients/persons, who order medicines through online platform.
  5. In the light of the fact that the authorities constituted under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 are competent to initiate appropriate action in the event of any infraction/violation of the said provisions and also conceded by the appellants herein, this Court is of the considered view that Paragraph No.38 of the impugned order requires to be stayed until further orders.
  6. In the result, there shall be an order of ad-interim stay of Paragraph No.38 of the impugned order dated 17.12.2018 made in W.P.No.28716 of 2018, until further orders.
  7. It is made clear that the reasons/observations made herein are only for the purpose of disposal of these miscellaneous petitions and this Court did not dealt with the merits of the main case and it is open to the respective parties to canvass the same at the time of final disposal of these writ appeals.
    Post all the writ appeals for final disposal on 24.01.2019”
  8. The above batch of writ appeals were listed for final hearing on 25.6.2024.

(It is learnt from open sources that on the recommendations of the Central Government and as per recommendations of a Committee, the Ministry of Health and Family Welfare, Government of India has prepared a draft Drugs, Medical Devices and Cosmetics Bill, 2022 in order to keep pace with changing needs, times, technology. There is no progress thereafter on the new bill.)

Now, the issue is whether the government has framed any policy with respect of regulate online sale of medicines and when the new policy or new Rules to regulate the online sale of medicines will be brought in?

Position of law as on date:

  1. The provisions of the Drugs & Cosmetics Act, 1940 and Rules thereunder (herein after referred as Act, 1940 and Rules, 1945) are to regulate import, manufacture, distribution and sale of drugs and cosmetics. The Part-VI of the Rules, 1945 specifies the sale of drugs other than Homoeopathic medicines. The Rule-65 of the Rules, 1945 specifies the conditions of license to sell medicines and no medicines in the country can be sold without complying with these requirements. No medicines in the country can be sold without license and if any person found selling medicines from a premise not licensed for the purpose of sale or exhibits for sale, shall be prosecuted under Section 27(b)(ii) of the Act, 1940. However, under the Rules, 1945 there is no provision that restricts to ship, mail or door delivery of the prescribed medicines.
  2. Union of India issued the draft amendment to the Rules, 1945 for inclusion of the rules to regulate online sale of drugs vide Notification No. G.S.R 817(E) dated 28.08.2018 and called for objections and suggestions from all the stakeholders. South Chemists & Distributors Association (SCDA) and All India Organisation of Chemists & Druggists (AIOCD) have submitted a detailed representation. The said Associations, in their representation, have made several important points, which require consideration by the Government. The comments / suggestions received are under due consideration before the Union of India for the draft rules to be finalised for publication in the official Gazette.
  3. The Hon’ble High Court of Delhi, vide its order dated 04.03.2024 in C.M. APPL. No. 13527 of 2024 in Writ Petition (C) No. 11711 of 2018, has stated that in pursuance to the last order dated 16.11.2023, the Joint Secretary (Ministry of Health and Family Welfare) is personally present and he prays for four months further time for framing the policy for online sale of drugs as per the draft notification dated 28.08.2018. The Hon’ble Delhi High Court has given the last and final opportunity to the Ministry of Health and Family Welfare to frame a policy of online sale of drugs within four months. The case stands posted to 8.7.2024.
  4. There is a larger public interest in regulating supply and use of drugs particularly in the context of the rising incidence of multi-drug resistant bacteria, a serious public health issue worldwide. There is apprehension that the easy access to antibiotics via online pharmacies will defeat this very purpose. Therefore, there is a need to amend the draft rules to include more stringent and specific provisions for ensuring the effective monitoring and supervision on online pharmacies. The government had received a lot of representations from various stakeholders on the draft rules and the majority of them had opposed the said draft rules of online sale of drugs. Considering the aforementioned facts, the government had not yet finalised the draft notification No. G.S.R 817(E) dated 28.08.2018 and the same are pending consideration.

Regards
N Ramesh
Senior Panel Counsel
Govt. of India

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