New Delhi: India’s drug regulator has banned the manufacture and sale of a specific formulation of a painkiller injection, diclofenac, marketed by Novartis India after a government panel raised concerns about its safety amid suspicions of pharmaceutical rivalry.

The Drug Controller General of India has ordered cancellation of the manufacturing licence granted to Themis Medicare for its diclofenac injection containing a compound called “Transcutol-P,” the Press Trust of India reported on Friday, quoting a government official. The order issued on July 4 also seeks the withdrawal of the drug’s stocks from the market.
The injection, manufactured by Themis, has been marketed by Novartis India under the brand name Voveran 1ml, for the past three years. A Novartis spokesperson said the injection had been marketed on the basis of regulatory approvals granted to Themis.

Over 110 million ampoules of the injection have been sold during this period, the spokesperson said.
A Gujarat-based drug company, Troikaa Pharmaceuticals, had claimed that the diclofenac injection containing Transcutol-P could cause damage to the kidneys.

A pharmaceutical website describes Transcutol-P as a “high-purity solvent and powerful solubiliser associated with skin penetration enhancement in topical dosage forms”.

Following Troikaa’s claims, two government panels had given opposing views on the injection. The health ministry had then asked a third panel of pharmaceutical experts to examine the claims that recommended more studies to establish safety.

“We were sensitive to the fact that our decision could have economic consequences for companies,” said Girish Sahni, the head of the third panel and director-general of the Council of Scientific and Industrial Research.

“We examined all data available to us and veered towards safety — we recommended another round of safety studies to completely establish safety,” Sahni told The Telegraph. 

“The decision to ban is a regulatory decision.” 

A Themis executive told this newspaper that the company had filed a writ petition in a court, challenging the decision.

A Themis spokesperson said Transcutol-P is in similar use in several countries, including South Korea and Russia. “There are no reports worldwide stating Transcutol P is toxic or toxic to the kidneys,” the spokesperson said.

“We are of the view that this matter has arisen due to business rivalry. However, we are refraining from further commenting since the matter is subjudice.” 

The Novartis spokesperson said Transcutol-P was specifically designed for use by the parenteral route and Gattefosse, (a French compaany), the global supplier of Transcutol-P, “has all the required safety and toxicology data”.

The spokesperson pointed out that the order relates only to diclofenac injection 1ml with Transcutol-P and does not affect any of the other diclofenac (Voveran) variants.

No one from Troikaa Pharmaceuticals was immediately available for comments.