Uttarakhand DC Revokes Themis mfg Licence for Diclofenac, Orders Product Recall

The Uttarakhand Drugs Controller has cancelled the manufacturing licence of Themis Medicare for diclofenac sodium injection 75 mg/ml using Transcutol-P and directed the company to recall the product from market following a notification by Drugs Controller General of India (DCGI).
The DCGI issued notice to Uttarakhand DC after a committee set up by health ministry found adverse effect of the drug on health. In Uttarakhand plant Themis Medicare was manufacturing the product under brand name, Aquadol which was being marketed by the company. It was also manufacturing the product at Daman and Diu plant which was being marketed by Novartis India under brand name, Voveran 1ml. Daman and Diu drugs control department was also directed by DCGI to cancel the product manufacturing licence of Themis.
Tajber Singh, Uttarakhand DC confirming this to Pharmabiz said, “On July 12 a notice was issued to Themis Medicare asking it to withdraw Aquadol from the market. We have also revoked the product manufacturing licence of the company.”
A panel was set up by Union ministry of health and family welfare under Girish Sahni, secretary, department of scientific and industrial research to examine the issue of Transcutol-P in injectable preparations of Diclofenac Sodium.
The Sahni committee in its recommendation to health secretary on December 27, 2017 stated that Transcutol-P as an excipient in parenteral formulation needs to be tested for its toxicity independently in order to establish its safety· since it is reportedly not an inert excipient. No evidence has been presented before the committee that it can be used in parenteral formulations even including India Pharmacopoeia especially on parenteral preparation for human use.
Likewise, the data in cumulative form, is indicative of its toxicity which entails a detailed study on its toxicity and safety profile in line with the observations given above. Whether the same could be permitted for use especially in parenteral formulation has to be decided by drug regulatory authority as per provisions of drug regulations on excipients to be used in parenteral form particularly those which are reportedly not inert, as in the present case, it said.
Sahni panel’s recommendations were essentially corroborative of the first committee set up previously. Its suggestions were in favour of rival Gujarat based pain management company Troikka Pharmaceuticals which manufactures injection to manage pain, Dynapar AQ. The product is competing with Voveran of Novartis Voveran 1ml, and Aquadol of Themis.
In 2015 Troikka had alerted Gujarat Food and Drugs Administration (FDA) about Themis’s diclofenac sodium 75mg/ml injection containing Transcutol-P, which causes kidney damage. Troikaa stated that Transcutol-P was not allowed for use in parenteral preparations globally. Gujarat FDA later alerted DCGI about Themis’s product.
Troikaa later approached DCGI and the health ministry to curb sales and revoke the licence of the product manufactured by Themis and marketed by Novartis.
The health ministry then formed an expert panel, which had come out with a recommendation supporting Troikaa’s stand.
Upset with this, Novartis approached the health ministry, which set up a second committee chaired by then Directorate General of Health Services (DGHS). The DGHS panel had found nothing wrong with Themis product, forcing Troikaa to file a petition in the Delhi High Court in 2016. Sahni committee was the third panel formed by the health ministry.
The ministry had presented Sahni panel report before the High Court which had on July 3 disposed of the Troikaa petition. According to AIOCD Pharma Trac, India’s pain management drugs market stands at Rs.2,000 crore, of them, diclofenac 1ml injection is Rs.260 crore.