Moneycontrol Be a Pro
Get App
Last Updated : Jul 08, 2019 05:50 PM IST | Source: Moneycontrol.com

Delhi High court dismisses Themis petition against ban of Diclofenac injection

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.

Viswanath Pilla @viswanath_pilla
Representative image
Representative image
 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

The 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.

Moneycontrol saw a copy of the order that ran into 45 pages delivered by Justice Vibhu Bakhru on July 5.

Close

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.

(Please read here for detailed story)

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.

Shares of Themis fell 10.58 percent and were trading at Rs 185 on July 8 at 2.18 pm, while the benchmark Sensex dropped 2.14 percent to 38,667.49 points. Novartis shares remained flat at Rs 652.

Themis spokesperson couldn't be reachable at the time of filing the story.

The Great Diwali Discount!
Unlock 75% more savings this festive season. Get Moneycontrol Pro for a year for Rs 289 only.
Coupon code: DIWALI. Offer valid till 10th November, 2019 .
First Published on Jul 8, 2019 05:47 pm
Loading...
NULL int(1)
Sections
Follow us on
Available On
PCI DSS Compliant