CELEBRITY BIOPHARMA LIMITED Vs. UNION OF INDIA

JUDGEMENT

(1.) Petitioner No.2 to 6 are directors of petitioner No.1 company under the name and style of M/s. Celebrity Biopharma Limited. Petitioner No.7 is the Deputy Manager, quality assurance of the petitioner No.1 company. The petitioners have prayed for quashing of proceeding in connection with Complaint Case No.C-156 of 2020 pending before the learned Metropolitan Magistrate, 13th Court, Calcutta whereby, the petitioner has been charged for violation of Sec. 18(a)(i) and Sec. 27 of the Drugs and Cosmetics Act, 1940 and all orders passed in the aforesaid complaint case including order dtd. 28/1/2020 passed by the learned Magistrate.

(2.) The petitioner No.1/company is engaged in manufacturing and distribution of pharmaceutical medicines through various supply chain. Petitioner Nos.2 to 6 being the director of the said company are not engaged in manufacturing and distribution process of drugs. However, they are involved in overall administration and finance of the said company. Petitioner No.7 is the Deputy Manager of the quality assurance team of the said company which consists of appointees by the Drug Controller cum license authority for quality assurance, formulation, process validation and various declarations which are required in terms of the Drugs and Cosmetics Act, 1940 (hereafter described as the said Act). The quality assurance team of the said company consists of officers having various designations and they are responsible for formulation of Drug and/or declaration which are to be made in respect of specific drug. Manufacturing and distribution of any drug go through a rigorous process, viz.,

(3.) On compliance of all the above measures, the petitioner No.1/company had got approval from the Health and Welfare Department of Baddi, Himachal Pradesh for manufacturing of a drug in the name and style of "Aceclofenac and Paracetamol Suspension" on and from 1/12/2015 to 11/2/2018. After complying of all the process as aforesaid, the company started production of the said drug. Certificate of analysis for the said drug was prepared by the quality team based on specifications which have been approved by the Drug Controlling Authority while issuance of the drug license. However, the specifications are not a stipulated declaration as per any Rules or Regulations, but these are the declaration of the range within which a result should lie. The concerned test results in respect of a particular batch of medicine is reflected on the certificate of analysis under result column and are final outcome of the tests which is conducted by the quality team of the petitioner/company. Pursuant to manufacturing testing and dispatch of a particular batch, it is up to the suppliers who use various modes and transportation to transfer a medicine to the retail chain.