THEMIS MEDICARE LIMITED Vs. UNION OF INDIA

JUDGEMENT

(1.) The petitioners have filed the present petition, inter alia, impugning the recommendations of an Expert Committee (as communicated by a letter dated 27.12.2017) constituted by Government of India under the chairmanship of Dr. Girish Sahani, Director General CSIR (hereafter referred to as 'the Third Committee') to, inter alia, examine and assess whether Transcutol P can be permitted for human use in parenteral formulations. The petitioners also impugn the communications dated 04.07.2018 and 09.07.2018 sent by respondent no. 5 (Drugs Controller General of India - DCGI) to Drug Licensing Authorities of the State of Uttarakhand and the Union territory of Daman and Diu to cancel the petitioner's licenses to manufacture Diclofenac Sodium Injection 75 mg/ml containing Transcutol P (hereafter "the drug in question"). The said communications were sent by DCGI on the basis of the letter dated 27.12.2017, issued by the Chairman of the Third Expert Committee and minutes of the meeting dated 20.12.2017 of the Third Expert Committee.

(2.) The petitioner in W.P. 7073 of 2018 (M/s Themis Medicare Limited - hereafter "the petitioner") is a pharmaceutical company which manufactures the drug in question - Diclofenac Sodium 75 mg/ml Injection - containing Transcutol P as an excipient under various brand names. Diclofenac Sodium injection 75 mg/ml is marketed by M/s Novartis India Limited (hereafter "Novartis") under the brand name "Voveran 1ml". The petitioner's patent for its injection is pending in India.

(3.) The petitioner in W.P. 8672 of 2018 (M/s Gattefosse, France - hereafter "Gattefosse") manufactures the Transcutol P used by the petitioner. Gattefosse is the sole manufacturer and supplier of Transcutol P for parenteral purposes.