Delhi High Court dismissed a petition filed by Themis Medicare challenging the ban imposed by the Drug Controller General of India (DCGI) on Diclofenac injection 75 mg/1ml marketed by its partner Novartis under Voveran 1ml brand. Diclofenac is used in the treatment of pain. Voveran is a Rs 250-crore product.
The DCGI early in July 2018 directed the state drug controllers of Uttarakhand, and Daman and Diu to cancel the manufacturing license granted to Themis for Diclofenac injection 75 mg/1 ml for using an excipient called Transcutol-P, on grounds that the substance is nephrotoxic leading to slow damage of kidneys. An excipient is an inert substance used in formulating a drug.
The DCGI decision was itself based on a report submitted by a seven-member committee under the chairmanship of Girish Sahni, the then Secretary, DSIR and Director General, CSIR.
The Sahni committee had recommended that Transcutol P as an excipient in parenteral formulation needs to be tested for its toxicity independently in order to establish its safety as it found no evidence that the same could be used in parenteral (injections) formulations.
Incidentally, Sahni Committee was the third expert committee that looked into the controversy that came into light in 2015, after Ahmedabad-based drug maker Troikaa and some clinicians filed complaints before the DCGI, alleging the use of Transcutol-P as excipient is not safe for injections and may lead to nephrotoxicity.
Themis disputed the recommendations of the third committee were "flawed as it had not addressed the terms and reference," and argued further that there is sufficient material to establish that use of Transcutol P in parenteral form is safe. Themis also called the decision-making process of the third Sahni Committee as false, and the Committee had finalised its decision in the absence of three members, including the toxicologist whose report didn't show any adverse toxicity. Themis also argued that the Committee didn't invite Gattefosse the maker of Transcutol-P to makes its submissions.
The Delhi High Court rejected these claims of the petitioner.
This Court finds no infirmity in the decision-making process of the Third Committee in recommending whether Transcutol P is required to be permitted in a parenteral formulation must be decided by the Drug Regulatory Authority as per the provisions of Regulations on excipient to be used in parenteral form.
"The onus of establishing that Transcutol-P is safe for use in parenteral form rests on the petitioner and the petitioner is required to discharge the same. It cannot be assumed that Transcutol P is safe unless proven otherwise. The approach of the petitioner that use of Transcutol-P must be accepted to be safe unless established to the contrary by respondents is flawed," the Court said.
"The Honourable Delhi High Court has vindicated our stand that it is necessary to establish the safety of the impugned product, before marketing the same," said Ketan Patel, CMD of Troikaa. The Court order was a huge setback for Themis.
[Courtesy: https://www.moneycontrol.com/news/business/companies/delhi-high-court-dismisses-themis-petition-against-ban-of-diclofenac-injection-4181851.html