Delhi HC Issues Notice To DCGI On Steps Taken Related To Approval Of Drugs With Identical Brand Names

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New Delhi : The Delhi High Court has issued notice to the Drug Controller General of India (DCGI) seeking clarification on the steps it has taken pursuant to a 2019 order which directed measures to ensure that medicines with identical brand names and identical packaging are not allowed to be manufactured or sold.

The Court was hearing a suit filed by Sanofi India Ltd against Ridley Life Science Pvt Ltd, in which Sanofi alleged that the latter continued to sell its products Conciflam and Coriflam, despite the injunction order passed on May 31, 2021. Sanofi alleges that these brand names are identical to its painkiller medicine trade mark Combiflam.

The Court, while hearing the suit, pulled up multiple suits filed by various companies alleging violation of their trade marks related to pharmaceutical preparations, against Ridley Life Science Pvt Ltd. Listing around 11 such cases and their orders, the Court observed that the orders shows that the company have repeatedly indulged in infringing and copying established trade marks used in respect of medicinal preparations.

In one such suit filed by Curewell Drugs and Pharmaceuticals against the company, in February 6, 2019, the Delhi High Court has directed the DCGI to conduct an inspection of Ridley’s products, in view of the various brand names/mark adopted by the company. However, Justice Prathiba M Singh, in her latest order on April 20, 2022, observed that it is unclear whether the DCGI had taken any action pursuant to the order.

In 2018, while hearing the matter, the Justice has observed that the State drug regulator has approved Ridley’s product with the mark Bevital, though it is identical to Curewell’s pre-existing mark Bevital, both for multi-vitamin supplements. It also cited a Supreme Court Order in a matter of Cadila Healthcare vs Cadila Pharmaceutical in 2001, which directed that the drug authority should consider requiring the applicant to submit an official search report from the Trade Mark Office pertaining to the trade mark if there is an indication of imitation or resemblance of another drug. The Delhi High Court issued a notice to the DCGI.

The DCGI during then, in response to the notice, submitted that there is no mechanism in place to implement the Supreme Court decision. The Court observed that if the products are sold with identical brand names, especially for different pharmaceutical compositions, the result could be life threatening to a patient and opined that the DCGI and State drug regulators should implement an action plan.

Following this, the DCGI informed that a draft rule is being prepared amending the Drugs and Cosmetics Rules to deal with the approval of identical brand names. The Court sought the authority to bring the draft rule in a stipulated timeframe and the ministry of health and family welfare issued the draft rule in February 26, 2019, amending the relevant rules to add a sub-rule that in case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking to the licensing authority that such or similar brand name or trade name is not already in existence so that the brand name or the trade name used by the applicant shall not lead to any confusion or deception in the market.

The Ministry submitted the draft with the Court and assured that the rule will be amended after the comments from the stakeholders are considered, not later than December 31, 2019, as per the Order on February 6, 2019. Justice Singh, taking this into consideration, in May 15, 2019, ordered that the suit need not be listed further.

In the Order on February 6, 2019, apart from the draft rules, the Court has directed the authority to consider various measures including creation of a secured platform under the supervision of DCGI, accessible to all state drug regulators, for access and uploading of data. It directed creation of a master electronic database of all the approved brand names for manufacture and sale of drugs issued both by the DCGI and State Food and Drug Administrations (FDAs) and making the same available to all the State FDAs and drug controllers.

The list has to be maintained and made available both brand wise and manufacturer wise, on the secured platform and the list of registered trade marks under Class 5 for pharma and medicinal preparations should be obtained from the Controller General of Patents, Trade marks and Designs be made to the due approving authorities and it should be updated bi-annually on January 1 and July 1, every calendar year, added the order. The drug inspectors need to conduct regular and period inspections to ensure that the drugs that are being manufactured in a particular unit are duly licensed for. Periodic meetings to review the status of manufacture and sale of drugs across the country has to be held at the central level, under the aegis of the DCGI and strict action should be taken against those manufacturers who manufacture drugs without licenses, who indulge in adulteration and contamination of drugs etc., added the order on February 6, 2019.

According to the latest order, the DCGI has to submit an affidavit as to what steps have been taken pursuant to these orders, at least one week before the next hearing. The suit is listed for hearing on May 26, 2022, now.

Besides, Ridley Life Science has been asked to deposit a sum of Rs. 1 crore with the Registrar General of the Court, at least one week before the next hearing, in a similar trade mark infringement litigation filed by Macleods Pharmaceuticals Ltd in 2018.

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