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Inj Voveran Banned: Drug regulator cancels licence for Diclofenac sold by Novartis


Inj Voveran Banned: Drug regulator cancels licence for Diclofenac sold by Novartis

The Drug Controller General of India (DCGI) further ordered for the withdrawal of the drug’s stock from the market.

New Delhi: India’s drug regulator has enforced a ban on the manufacture and sale of painkiller injection, Diclofenac, made by Themis Medicare and marketed by Novartis India Ltd under the brand name Inj Voveran 1ml, after a Health Ministry panel raised concerns over the medicine’s impact on health.

Medical dialogues had earlier reported that a panel from health ministry had raised concerns over the safety of diclofenac injection. The panel was responding to the allegations raised a by Gujarat based Pharma Company on the safety of the Novartis Drug

Read also: Voveron 1ml causes Kidney Damage: Health Ministry panel recommends toxicity check for component

“The DGCI ordered for the cancellation of the manufacturing licence granted to Themis Medicare for Diclofenac sodium injection 75 mg/ml, containing Transcutol-P …on July 4,” a government official said.

The Drug Controller general of India (DCGI) further ordered for the withdrawal of the drug’s stock from the market.

The order came as a shot in the arm for Troikaa Pharmaceuticals Ltd, based in Gujarat, which had claimed that the diclofenac sodium 75mg/ml injection contained Transcutol-P which caused damage to the kidneys. . As per pharmaceutical market research firm AIOCD Pharma Trac, Troikaa and Novartis together command over 60% market share of 1 ml diclofenac, which is estimated to be worth around Rs 2000 crore.

Diclofenac injection was marketed by Novartis under the brand name Voveran 1ml.

It is reported that following allegations by Troikaa, which had approached the Health Ministry to stop the injection’s sales, the government had formed a panel to review its safety in 2015. The panel submitted a report favouring Troikaa.

A second committee was formed after Novartis moved the Health Ministry which gave a clean chit to the company prompting Troikaa to approach the Delhi High Court in 2016.

“A third committee was then formed under Girish Sahni, director general, Council of Scientific and Industrial Research (CSIR), in May last year which in its report, submitted in December, backed the claims made by Troikaa,” the official said.

The DCGI has directed the state drug controller in Dehradun, Uttarakhand, and the drug licensing authority of Daman and Diu to cancel the license granted to M/s Themis Medicare to manufacture for sale of Diclofenac injection 75 mg/ml containing Transcutol-P, the official said.




Source: self
11 comment(s) on Inj Voveran Banned: Drug regulator cancels licence for Diclofenac sold by Novartis

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  1. It is welcome . Doctors use drugs without noting the ingredients . But how many ayush products have scientfic basis of drug definition . Indians donot know what they are getting for their treatment. Absuletly no regulations so sad .

  2. Ayush medicine also sold after the proper drug testing by DTL.so stop this shit to blame for all in ayush system. this is not a Stone age to people accept all. ayush also modernising in drug safty

  3. user
    Dr M S SUDHINDRA July 15, 2018, 9:00 pm

    If the issue was raised in 2015 .Govt took 3yrs to decide. .This delay has to be explained. If voveran 1.5ml contains transcutol-p,even diclofenac 1ml also must be containing transcutol-p..Why allow Voveran 1ml to be marketed. This needs clarification. .

  4. user
    Dr Ramesh Vardhan July 14, 2018, 11:45 am

    TRANSCUTOL-P WHICH IS STABILIZER IN INTRAVENOUS DICLOFENAC IS MORE LIKELY TO DAMAGE THE KIDNEYS/ NEPHROTOXIC. NOVARTIS MARKET IT\’S DICLOFENAC AS VOLTARAN IN THE WESTERN COUNTRIES, WEHER AS IN INDIA AS VOVERAN . THIS MAY BE ONE OF REASON . TRANSCUTOL-P IS A BANNED IN THE WEST , WHERE AS IN THE THIRD WORLD COUNTRIES ANY THING AND EVERY THING SOLD IN THE NAME OF A MEDICINE. ( NEITHER THE DOCTORS NOR PATIENTS ARE REALLY AWARE OF THE ILL EFFECTS THESE CHEMICALS . I AM NOT SURE HOW MANY POOR, INNOCENT AND HELPLESS PATIENTS HAVE LOST THEIR KIDNEYS BECAUSE OF THE WRONG TREATMENT/ DRUGS . I THINK INDIA IS THE WORLD\’S HIGHEST DUMPING GROUND FOR ALL SORTS DRUGS. CAN YOU BELIEVE THE LIFE EXPECTANCY OF THE INDIAN DOCTORS MUCH LESS THAN THAT OF THEIR OWN PATIENTS/ CITIZENS , MAY BE TAKE ALL SORTS OF FUNNY MEDICINES WITH GOOD FAITH OR WRONG ADVICE BY ILLTRAINED MEDICAL REPRESENTATIVES. ( IT COULD BE DUE TO EXCESS OF FREE FOOD AND FREE DRINKS BY THE PHARMA AND SO CALLED CORPORATE HOSPITALS).

  5. CANNABIS WILL COME BACK LEGALLY IF ALL THE PAIN KILLERS ARE GRADUALLY STOPPED.GOOD THEN, ITS ALREADY A PAIN KILLER AND ON THE PRETEXT OF SHIVAS PRASAD, IT WILL SAVE PEOPLE FROM PAIN AND SUFFERING..HEHE.

  6. What about oral form of diclofenac or any other brand of diclofenac, ?

  7. This development has happened only due to presence of Transcutol P in Voveran injection. Such substance is not present in oral formulation.