Glenmark Pharmaceuticals Limited vs Sanjeevni Medicos And Ors on 23 May, 2023

[Cites 4, Cited by 0]

Delhi High Court - Orders

Glenmark Pharmaceuticals Limited vs Sanjeevni Medicos And Ors on 23 May, 2023

$~37
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CS(COMM) 38/2023
GLENMARK PHARMACEUTICALS LIMITED ..... Plaintiff
Through: Mr. Ranjan Narula, Mr. Shashi Pratap
Ojha and Ms. Shivangi Kohli,
Advocates.

versus

SANJEEVNI MEDICOS AND ORS. ..... Defendants
Through: Mr. Vaibhav Kalra, Advocate for D-
1.
Mr. Aditya Hooda, Advocate for D-2.

CORAM:
HON'BLE MR. JUSTICE SANJEEV NARULA
ORDER

% 23.05.2023 I.A. 10047/2023 (on behalf of Defendant No. 2 under Order XXXIX Rule 4 r/w Section 151 of the Code of Civil Procedure, 1908 ["CPC"] seeking variation of order dated 20th January, 2023)

1. Defendant No. 2, Safdarjung Medicos, has been subjected to a restraining order dated 20th January 2023 [referred as "impugned order"], which prohibits them from engaging in various activities related to pharmaceutical preparations under the trade names 'TELMA' and 'TELMA- AM' [referred as "pharma preparations"]. Defendant No. 2 now seeks a modification of the order to lift the restriction on stocking, selling, and offering for sale the aforementioned pharma preparations. Similarly, Mr. Vaibhav Kalra, counsel for Defendant No. 1, Sanjeevni Medicos, also makes an oral request on behalf of his client for the same. Before addressing the CS(COMM) 38/2023 Page 1 of 7 This is a digitally signed order.

The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 25/09/2023 at 00:15:02 requests made by Defendant Nos. 1 and 2 [referred collectively as "Pharmacists"], it is appropriate to provide a brief background of the case for better understanding.

2. Plaintiff, Glenmark Pharmaceuticals Ltd., manufacturer of pharma preparations in question was alerted about Defendant Nos. 1 and 2/ Pharmacists selling the said infringing pharma preparations which, according to them, were spurious and fake/ counterfeit drugs.

3. Considering the fact that sales were made by the Pharmacists under tax paid invoices (also mentioning the batch numbers) and overall remarkable similarity between Plaintiff's genuine pharma preparations vis-à- vis counterfeit products and gravity of the situation, while granting injunctive reliefs, this court, keeping in mind consumer welfare and the interest of public at large, issued further directions to Deputy Commissioner of Police (Crime), South West, New Delhi and the Drug Inspector, South West District, New Delhi.

4. The next returnable date is set for 06th July, 2023, and the court anticipates that both the afore-mentioned state entities would have, by then, fulfilled the directions outlined in the impugned order. The court also expects the reports, as directed, to be available for review. Nevertheless, as a reminder, Plaintiff is instructed to serve a copy of this order to ensure prompt compliance.

5. The Pharmacists have submitted affidavits revealing the names of the entities from whom they purchased infringing/ counterfeit pharma preparations bearing batch No. 18210538. Defendant No. 2 made purchases from 'Metro Pharma' and 'SAMS Pharma Pvt. Ltd.', while Defendant No. 1 purchased from 'SAMS Pharma Pvt. Ltd.' and 'Paras Pharma' [all three CS(COMM) 38/2023 Page 2 of 7 This is a digitally signed order.

6. Prima facie, it appears that Pharmacists have purchased these products from the Stockists mentioned above, under a belief that the source is genuine. They, in fact, urge that in past, they have been purchasing other pharmaceutical products/ preparations from the said entities/ Stockists for last several years.

7. Taking note of the above fact, the court heard Mr. Ranjan Narula, counsel for Plaintiff as well as counsels for Pharmacists to understand Plaintiff's chain of supply of pharma preparations. Ms. Seema Manku, Senior Vice President (Legal) of Plaintiff has also been heard.

8. It has come to light that Plaintiff manufactures pharmaceutical products and preparations, including the specific pharma preparations in question, either through their own factories or through third-party arrangements. As elucidated by Mr. Narula, the products manufactured at Plaintiff's manufacturing facility/ facilities are subsequently transferred to warehouse(s). From warehouses, they are distributed to "Super Distributors", who are directly appointed by the Plaintiff or its Authorized Representative(s). These "Super Distributors" then sell products to "Authorized Stockists", whose appointments are duly notified to the Plaintiff. Mr. Narula clarifies that the Plaintiff does not have direct contractual privity with these "Authorized Stockists". Such stockists, in turn, sell products to "Retailers", and ultimately, the products are purchased by consumers/ customers. Considering the information shared by Pharmacists, Mr. Narula makes an oral request to include the Stockists (unauthorised) as Defendants in order to investigate how spurious pharma preparations has infiltrated the supply and distribution chain.

CS(COMM) 38/2023 Page 3 of 7

This is a digitally signed order.

The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 25/09/2023 at 00:15:02

9. Mr. Kalra brings another troubling aspect to court's attention. He reveals that following the impugned order, a Drug Inspector visited Defendant No. 1's premises and seized all pharma preparations in question ('TELMA' and 'TELMA-AM'). The Drug Inspector subsequently submitted a report (dated 10th April, 2023), disclosing that in addition to the batch already known to the court, another batch being No. 18220076 has also failed the test. Mr. Kalra assures to provide a copy thereof to Mr. Narula so the Deputy Commissioner of Police can be informed of this new development, which can assist them in further them in further investigation. This revelation suggests that neither the Plaintiff nor the Pharmacists were aware of the existence of these additional batches of spurious pharma preparations. Mr. Kalra emphasizes that this specific batch was supplied to Defendant No. 1 by 'SAMS Pharma Pvt. Ltd.' (one of the unauthorised Stockists).

10. Considering the significant implications for public health, the court has raised concerns with Mr. Narula and Ms. Manku regarding the measures being undertaken by the Plaintiff to uphold the integrity of the supply chain. In response, Mr. Narula refers to a notification issued by the Ministry of Health and Family Welfare on 17th November, 2022 (under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940). This notification, scheduled to come into effect on 01st August, 2023, is seen as a relevant reference point. According to Mr. Narula, this notification is expected to address the issue at hand. However, he states that he will need to deliberate with his clients before making further submissions to how the said notification will be implemented. Additionally, Ms. Manku asserts that Plaintiff-Company is fully compliant with the existing rules and regulations issued by the CS(COMM) 38/2023 Page 4 of 7 This is a digitally signed order.

11. Keeping aside the issue of regulatory compliance by the Plaintiff, the court has also inquired about the best industry practices followed internationally by the Plaintiff and similar entities to combat the circulation of counterfeit or fake drugs. On this matter, Mr. Aditya Hooda, counsel for Defendant No. 2, has informed the court that robust legislations exist worldwide, which are stringent in addressing the public hazards associated with drug pilferage and adulteration. He further highlights that drugs and pharmaceutical products incorporate serialization and tracing mechanisms to combat counterfeiting, a practice that Indian pharmaceutical companies also adopt for exported pharmaceutical products/ formulations.1 The purpose of this serialization and tracing mechanism is to address counterfeit/ adulterated/ ineffective product recall challenges, which effects the entire healthcare supply chain (manufacturers till patients, wholesalers, distributors, exporters and healthcare providers). Drug preparations/ formulations exported are inter alia mandated to carry a one/ two- dimensional barcode encoding a universal global product identification code in the form of a 14-digit Global Trade Item Number (GTIN), along with the product's batch number, expiration date, and unique serial number.

12. Taking note of the above, the Court has further queried from Mr. Narula and Ms. Manku whether such practice can be adopted domestically. In court's view, the integrity of the supply chain is of paramount importance when it comes to safeguarding public health and safety. Serialization processes can play a crucial role in this regard. By implementing 1 See: Para 2.90 A ("Track and Trace system for export of drug formulations"), Handbook of Procedure 2015-20 issued by Directorate General of Foreign Trade, Ministry of Commerce and Industry.

CS(COMM) 38/2023 Page 5 of 7

This is a digitally signed order.

The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 25/09/2023 at 00:15:03 serialization, which involves assigning unique identifiers to each drug product, the industry can effectively track and trace these such products/ formulations throughout the supply chain. This process acts as a powerful tool in combating the circulation of counterfeit or fake drugs, promoting public safety. Mr. Manku and Mr. Narula have assured to share further inputs on these issues with the court.

13. In the meantime, Mr. Kalra as well as Mr. Hooda, counsel for Defendant Nos. 1 and 2 respectively, request that they may be permitted to sell pharma preparations in question.

14. In view of the fore-going, the following directions are issued:

(i) Pharmacists (Defendant Nos. 1 and 2) are permitted to sell pharma preparations ('TELMA' and 'TELMA-AM'), provided they purchase them from any of the "Authorised Stockists", list whereof shall be furnished by Mr. Narula to above-mentioned counsels, forthwith.

(ii) Pharmacists shall maintain a complete record of pharma preparations ('TELMA' and 'TELMA-AM') purchased by them and file an affidavit, to that effect, every six months before this court.

(iii) Mr. Kalra shall provide the Drug Inspector's report to Mr. Narula, who shall further transmit it for investigation to concerned police authorities. Mr. Kalra as well as Mr. Hooda shall render full assistance to Mr. Narula for collating the information that is required to be transmitted to police authorities.

(iv) The Stockists 'Metro Pharma', 'SAMS Pharma Pvt. Ltd.' and 'Paras Pharma' are impleaded as Defendants in the present suit. Amended memo of parties be filed within a period of one week from today.

(v) Upon filing of process fee, issue summons to such newly impleaded CS(COMM) 38/2023 Page 6 of 7 This is a digitally signed order.

(vi) On the next date of hearing, Mr. Narula as well as Ms. Manku shall share information regarding practices that can be adopted by Plaintiff to avoid such spurious sale of pharmaceutical products (including pharma preparations in question).

15. Disposed of in above terms.

CS(COMM) 38/2023

16. At request of counsel for parties, the matter shall be treated as 'part- heard.'

17. List before the Joint Registrar on the date already fixed i.e., 01st June, 2023.

SANJEEV NARULA, J MAY 23, 2023 d.negi (Corrected and released on: 27th May, 2023) CS(COMM) 38/2023 Page 7 of 7 This is a digitally signed order.

The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 25/09/2023 at 00:15:03

Unlock Advanced Research with PRISMAI

Delhi High Court - Orders