Drug controller general of India (DCGI ) cancels licence for diclofenac sold by Novartis after concerns raised by a health ministry panel
India’s drug regulator has ordered the withdrawal of the popular diclofenac painkiller injection marketed by Novartis India and made by Themis Medicare, following safety concerns raised by a a health ministry panel.
The drug controller general of India (DCGI) on July 4 directed the state drug controller in Dehradun, Uttarakhand, and the drug licensing authority of Daman and Diu to cancel the manufacturing licence granted to Themis Medicare for diclofenac sodium injection 75 mg/ml using Transcutol-P. Mint has reviewed a copy of the letter.
The order comes as a victory for Gujarat-based Troikaa Pharmaceuticals, a rival pain management injection manufacturer, which had waged a two-year battle. Troikaa had alleged that diclofenac sodium 75mg/ml injection contains Transcutol-P, which causes kidney damage.
Diclofenac injection is marketed by Novartis under the brand name Voveran 1ml, and Themis’s brand Aquadol had competed with Troikaa’s injection to manage pain, Dynapar AQ.
India’s pain management drugs market is around INR 2,000 crore, of which diclofenac 1ml injection is INR 260 crore. As per pharmaceutical market research firm AIOCD Pharma Trac, Troikaa and Novartis together command over 60 per cent market share of 1 ml diclofenac.
The efficacy and safety of the additive Transcutol-P came under the scanner after Troikaa claimed that it was not used anywhere in the world, and was not permitted for use in parenteral preparations, meaning that it cannot be used in intravenous or intramuscular injections. It also alleged that Themis Medicare manufactured a version of Diclofenac Inj 75mg in 1ml with Transcutol-P to avoid infringing Troikaa’s patent.
In 2015, Troikaa approached DCGI and the health ministry to stop sales and cancel the license of the painkiller injection manufactured by Themis and marketed by Novartis. The government then set up an expert committee, which submitted a report favouring Troikaa.
However, Novartis moved the health ministry, after which a second committee was formed under the then Directorate General of Health Services (DGHS). This committee gave a clean chit to Novartis, prompting Troikaa to approach the Delhi high court in 2016.
According to a government official, who spoke on condition of anonymity, a third committee was formed after Union health minister JP Nadda intervened in the matter. The panel was formed under Girish Sahni, director general, Council of Scientific and Industrial Research (CSIR), in May last year. The Sahni panel, which submitted its report on 29 December, backed Troikaa’s claims. The committee also did not find any evidence supporting the claims of Novartis and Themis, two people aware of the matter said on condition of anonymity, adding that the panel has recommended that Transcutol-P be independently tested for toxicity.
“Transcutol-P as an excipient in parenteral formulation needs to be tested for its toxicity independently in order to establish its safety. No evidence has been presented before the committee that it can be used in parenteral formulations, even including Indian pharmacopoeia, especially on parenteral preparation for human use,” said the committee.
Subsequently, the committee report was placed before the Delhi high court. “The court in its order dated July 3 disposed of the petition,” said one of the officials quoted before. According to Themis, by last year, about 125 million injections of the product had been sold by Themis-Novartis.
A doctor said he avoids using the painkiller. “This is known to be toxic if used on a regular basis. We don’t normally use it,” said Dr Sandeep Guleria, senior consultant at Indraprastha Apollo hospital.
While Troikaa declined to comment, Novartis said the company is yet to receive a recall letter from the drug controller. “We would like to clarify that we at Novartis have not received any communication from the regulatory authorities asking us to recall diclofenac 1ml injections from the market. Novartis would respond to any concerns that the regulatory authorities may have about diclofenac 1ml, should it receive any communication from them in this regard. Diclofenac 1ml is being marketed in India for over three years based on approvals granted to the manufacturer Themis Medicare. Diclofenac 1ml forms a very small part of the larger Novartis in India portfolio. At Novartis we are committed to providing patients with high quality medicines and patient safety is at the core of everything we do,” said a spokesperson for Novartis. Themis did not respond to Mint queries till press time.