FDC Drugs: Delhi HC lifts ban on Combikit used for syndromic management of STDs

In one of several challenges to the ban on the manufacture, sale or distribution of Fixed Dose Combination (FDC) drugs in India, the Delhi High Court has set aside the notification banning the Combikit of Azithromycin, Secnidazole and Fluconazol..While setting aside the ban, the Court has held that recourse to Section 26A of the Drugs and Cosmetics Act, 1940 is unavailable to prohibit prescription of a therapy or packaging of drugs in any particular manner..The judgment was passed by a Single Judge Bench of Justice Vibhu Bakhru in petitions by manufacturers and sellers of the Combikit, Hetero Healthcare and Biostrass Therapeutic Inc, under the brand names FAS-3 KIT and CANTRAS KIT..The Combikit is a convenient package containing three separate drugs and is recommended for syndromic management and treatment of Sexually Transmitted Diseases (STDs). Each individual formulation operates as an antibacterial, anti-fungal and anti-trichomonal treatment..While considering the question of banning FDCs, the sub-committee had recommended prohibiting the Combikit on the ground that it had no therapeutic justification. It observed that the drug might involve risk to human beings, and hence it was necessary to prohibit the manufacture, sale or distribution of the Combikit under Section 26A..The Court, however, held that the Combikit was not a drug, and thus not an FDC..“The four tablets are packaged in a single strip and sold as the Combikit. The petitioner is licensed to manufacture each of the said formulations… the batch number of each of the drugs is separate and is separately written on the strip as well as on the box in which the strip is packed. Similarly, the date of manufacture and expiry of each of these tablets has been separately printed.”.The Court also recorded that the petitioner’s application to the Drug Comptroller General of India (DCGI) seeking approval for manufacturing the Combikit as an FDC was also rejected..Since the Combikit could not be treated as a single drug or an FDC, the provisions of Section 26A of the Act were wholly inapplicable to it, the Court held..The Court also refused to accept the respondent’s argument that the therapy entailing the drugs in the Combikit was irrational, and hence could not be permitted..“There might be good reasons not to prescribe such therapy, however, the provisions of Section 26A could not be pressed into service for proscribing a therapy”, it said..It further said that issues with respect to packaging of the three separate drugs in one single package would have to be addressed in the context of the regulations relating to packaging of drugs..Th notification banning the Combikit was thus set aside..The petitioners were represented by Senior Advocate Abhinav Vasisht with Advocate Bina Gupta, Priya Singh, Kshitij Vaibhav, Avinash Tripathi and Binay Kumar..The respondents were represented by Additional Solicitor General Maninder Acharya with Central Government Standing Counsel Anurag Ahluwalia and Advocates Abhimanyu Singh, Abhigyan Sidhant and Viplav Acharya..Read the Judgment: