Voveran 1ml causes Kidney Damage: Health Ministry Recommends Toxicity Check

Diclofenac injection is a painkiller which is manufactured by Themis Medicare Ltd and marketed by Novartis India under the brand name Voveran 1 ml Injection.

Troikaa Pharmaceuticals had alleged that the painkiller injection diclofenac Sodium 75 mg/ml contains Transcutol, which damages kidneys and filed a petition in Delhi High Court against the granting of manufacturing licenses for the painkiller and allowing its marketing by Novartis AG.

Troikaa has developed and sells Diclofenac Sodium 75 mg/ml injection under the brand name ‘Dynapar AQ’, which is patented globally.

The petition stated that Themis to avoid patent infringement, is manufacturing a different version of its Diclofenac Sodium 75 mg/ml injection and Novartis is marketing it.

The petition further stated that Themis and Novartis have conveniently ignored the fact that Transcutol P is not recommended for parenteral use Regulatory bodies in US, Europe, and other parts of the world do not permit it’s parenteral use, as it is known to cause injury to kidneys.

During the hearing, the court had formed an expert panel to review the safety of Transcutol-P who gave their recommendations in favor of Troikaa. Novartis then approached the health ministry after which the second panel was formed under the Directorate General of Health Services. The second panel gave their decision in favor of Novartis.

Another panel was formed under Girish Sahni, director general, Centre of Scientific and Industrial Research (CSIR), in May after the contradictory reports on Troikaa’s allegations.

The which submitted its report on 29 December, endorsed Troikaa’s submissions. The committee also did not find any evidence supporting the claim of Novartis and Themis, two people aware of the matter said, adding that the panel has recommended that Transcutol-P be independently tested for toxicity. 

Sahni panel, A spokesperson for Themis maintained that product is absolutely safe and told , “Post our meeting with the committee sometime in July 2017, we do not have any further status on the subject from authorities, hence unable to comment.”

Troikaa Pharma gets patent approval for Dynapar AQ in CIS

Ahmedabad, India -based mid-sized pharmaceutical firm, Troikaa Pharmaceuticals Ltd has been granted the patent for ‘Dynapar AQ’, a diclofenac or painkiller injection, for the CIS block earlier this week.

Commonwealth of Independent States or CIS countries include Ukraine, Kazakhastan, Belarus, Uzbekistan, Turkmenistan, Kyrgystan, Russia among others.

“The CIS block is a significant market for us and we expect huge demand for Dynapar AQ in these countries,” said Ketan Patel, managing director, Troikaa Pharma, adding that he is eying a 25 per cent market share in all the new markets that it enters with this product.

Troikaa was granted patent for Dynapar AQ in Australia last year, which was the first one among regulated markets, and subsequently it had also entered the African countries. “We are also expecting patent approvals in the United States, EU and Canada within the next few weeks. The company has spent about Rs 3 crore on this endeavour but will reap manifold dividends in return.”

Diclofenac injections are used for management of painful inflammatory conditions. Dynapar AQ is a unique high concentration, low viscosity injection of diclofenac sodium delivering the full therapeutic dose of diclofenac in just one millilitre injection volume. It is the only diclofenac injection available in PFS (pre-filled syringe) form.

Compared to conventional diclofenac injections, Dynapar AQ causes negligible pain and can be injected in the upper arm, unlike the conventional one injected in the buttocks. Dynapar AQ Injection is ranked second in the highly competitive diclofenac injections category on ORG-IMS and slated to become the top brand by mid-2010.

The company holds patented technology platforms for various Novel Drug Delivery Systems, Intra-oral, Oral, Parenteral, Sustain Release & Topical for diclofenac. The company sought global protection for its product by filing a Patent Cooperation Treaty(PCT) application with the World Intellectual Property Organisation (WTPO). Subsequently, the company filed for global patents in 99 countries, which included regulated as well as non-regulated countries.

“Leaving the US and the EU apart, in all the other countries the landed cost of diclofenac injections is around three to five cents while it sells at around $2 for a single dose. We can easily garner a huge market share by positioning our product in a lower price bracket,” said an upbeat Patel. It enjoys a 40 per cent market share in Diclofenac injections in India and hopes to take it up to 60 per cent within this fiscal.

There is huge opportunity in the US that currently uses Kitorolac in place of Diclofenac, Patel felt while adding that exact market size estimates were not available. The company’s exports have steadily risen from 18 per cent of its turnover in 2008-09 to around 25 per cent of turnover in 2009-10. It registered revenues over Rs 145 crore in 2009-10 and aims to record a 40 per cent growth in turnover in 2010-11.

It has manufacturing facilities located in Ahmedabad and Dehradun (Uttaranchal). The Ahmedabad facility located at Thol, an industrial area 25 kilometers from the city and manufactures critical care injectables, tablets and topical preparations.

Buoyed by the demand for its injectable Dynapar AQ, for which it has been granted patent in around 40 countries so far, the company now plans to shift part production of Dynapar AQ to its upcoming Sanand facility from Dehradun.