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Inj Voveran Ban: Delhi High Court denies relief to manufacturer Themis Medicare, Dismisses Petition


Inj Voveran Ban: Delhi High Court denies relief to manufacturer Themis Medicare, Dismisses Petition

New Delhi: Denying relief to Themis Medicare, the manufacturer of the popular painkiller Inj Voveran 1ml (Diclofenac), that as marketed by Novartis and was banned last year by the Indian Drug Regulator, DCGI the Delhi High Court recently dismissed the petition of Themis challenging the ban.

Medical Dialogues had earlier reported that last year, India’s DCGI had 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 it using an excipient called Transcutol-P, on grounds that the substance is nephrotoxic leading to slow damage of kidneys.

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

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The roots of this ban go back to 2015 when a small Ahmedabad based company,  Troikaa Pharmaceuticals began alleging that its rival brand of Diclofenac injection a painkiller manufactured by Themis Medicare Ltd. and marketed by Novartis India under the brand name Voveran 1ml injection, is nephrotoxic. It also alleged that Themis Medicare manufactured a version of Diclofenac Inj 75mg in 1ml with Transcutol-P to avoid infringing Troikaa’s patent

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With questions on the safety of Transcutol-P being raised, Health Ministry constituted not one, but three committees to look into the matter, with varied conclusions. The Third and the last Committee recommended that Transcutol P as an excipient in parenteral formulations, needs to be tested for its toxicity independently in order to establish its safety as it found no evidence that the same could be used in parenteral formulations.  This lead to the DCGI enforcing a ban of the manufacture and sale of the drug.

The ban was challenged by Themis in the Delhi HC. The counsel for the petitioner before the court stated that d that the findings of the Third Committee are perverse, illegal, arbitrary and devoid of any reasons. It was also contended  that the decision of the respondent authorities to constitute the Third Expert Committee was also arbitrary and unreasonable.

It was contended on behalf of the Themis that there are no safety issues with regard to use of Transcutol P in a parenteral form and the same has been approved by CDSCO in 2010 in another formulation. It was stated that CDSCO had approved Tolperisone Injection in 2010 and the said formulation contained Transcutol P as an excipient. The petitioner contended that the Third Committee had failed to consider that clinical trials for Tolperisone Injection containing Transcutol P were conducted and its safety for human use was established.
It was contended on behalf of the petitioner that Troikaa had manipulated and misled various drug agencies regarding the use of Transcutol P in parenteral formulations. It was submitted that this was a case of business rivalry and the decision of the respondents to form a Committee was unwarranted. It was also contended that more than thirteen crore ampoules of the drug in question had been sold and there is no report of any serious adverse event. Therefore, there could be no issue regarding the safety of the Transcutol P as an excipient
The counsel appearing for Troikaa submitted that the drug manufactured by the petitioner Themis was not identical inasmuch  as it used the excipient Transcutol P, which was different from the excipient contained in Dynapar AQ; nonetheless, the petitioner had not furnished any safety data or conducted any clinical trials in obtaining
approval of its drug
The Delhi HC bench of Justice Vibhu Bakhru went in detail into the matter including going through the three committee reports and the international evidence on Transcutol P. The bench after going through the evidence noted
…undisputedly, the drug manufactured by the petitioner, Voveran using Transcutol P as an excipient has not been approved by DCGI. The petitioner has not gone through the process as provided under the Rules for seeking approval of the said drug as a new drug. On the contrary, it is obtained its license to manufacture on the basis that the drug manufactured by it is not a new drug. This is difficult to accept because the drug approved by DCGI, Dynapar AQ – on the basis of which the petitioner has obtained the license to manufacture the drug in question – does not contain Transcutol P as an excipient…..
On the issue of the inertness of Transcutol P, the court noted
…..Although the petitioner has sought to challenge the finding that Transcutol P is an inert substance, it has not produced any material to establish that Transcutol P is an inert substance. It had merely referred to the handbook of pharmaceutical excipient and had relied upon the statement contained therein that DEGEE “is generally regarded as nonirritant and non-toxic”. This is, plainly, not the same as being inert which would imply that the substance is chemically inactive…..
…The onus of establishing that Transcutol P is safe for use in parenteral form rests on the petitioner and the petitioner is required to discharge the same. It cannot be assumed that Transcutol P is safe unless proven otherwise. The approach of the petitioner that use of Transcutol P must be accepted to be safe unless established to the contrary by the respondents, is flawed….
…It was contended on behalf of the petitioner that while applying for a license to manufacture the drug in question, it had provided the necessary evidence and data justifying that the use of the drug in question was safe in the context of the excipient Transcutol P. This was contested by the respondents and it was submitted that the petitioner had obtained the license to manufacture the drug in question based on the approval granted to Troikka earlier. There is no material on record indicating that the petitioner had presented data justifying that the use of excipient Transcutol P is safe while applying for the license to manufacture the drug in question. On the contrary, it is the petitioner’s  assertion that the drug in question was not a new drug and, therefore, the petitioner was granted a license to manufacture the same by the State Drug Licensing Authorities…..
On the question of the legality of the Third Committee, the court noted
….It is contended on behalf of the petitioner that the constitution of the Third Committee is illegal and it was done at the behest of Troikaa. However, this Court finds no illegality in the constitution of the Third Expert Committee. It is possible that the Committee was constituted on the complaints/representations made by Troikaa. However, the same does not render the decision to constitute the Third Committee as illegal. The decision whether the recommendations by a Committee required any further review is plainly at the discretion of the concerned authority…..
….The Third Committee was constituted by an order dated 03.05.2017 to, inter alia, examine and assess whether there was sufficient evidence about the toxic effect of Transcutol P which made it unsafe for use in parenteral preparation and whether use of Transcutol P in parenteral preparation were required to be banned. The Committee was also to assess whether Transcutol P could be permitted for human use. Clearly, the Committee was unable to answer the said issues as it found that there was lack of sufficient evidence and material for it to do so. However, it concluded that there was a requirement to test Transcutol P as an excipient for its toxicity independently to establish its safety. Thus, while it is correct that the Third Committee did not answer the issues raised, nonetheless, its recommendations cannot be faulted. It is also relevant to note that the Committee was not formed under any statute and its recommendations do not have a statutory flavour. The Third Committee was constituted merely as an expert committee to submit its recommendations to the regulatory authorities….
Noting that the communication sent by the DCGI to Drug Licensing Authorities of the State of Uttarakhand and the Union Territory of Daman and Diu (calling for the ban) cannot be faulted, the court said that DCGI had called upon the said Drug Licensing Authorities to cancel the license granted to the petitioner to manufacture the drug in question, as the drug in question using Transcutol P as an excipient had not been approved as per the Rules.
The court then dismissed the petition filed by Themis
You can read the judgement by clicking on the following link

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