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2022 Supreme(Cal) 359
IN THE HIGH COURT OF CALCUTTA
Bibek Chaudhuri, J.
Celebrity Biopharma Limited And Others - Appellant
Versus
Union Of India - Respondent
IA No. :CRAN/1/2021 in CRR 553 of 2021
Decided On : 06-09-2022
Mr. Anirban Dutta, Adv., Mr. Sumit Biswas, Adv., Mr. Sarangam Chakraborty, Adv., Mr. Shashwat Nayak, Adv., Ms. Rajashree Bhowmick, Adv., for the Appellant; Mr. Rajdeep Mazumder, Adv., Mr. Pritam Roy, Adv., for the Respondent
The judgment emphasizes the mandatory nature of statutory provisions and the need for strict compliance with procedural requirements.
Headnote:
Drugs and Cosmetics Act - Violation of Section 18(a)(i) and Section 27 - [1940 Act, Section 18(a)(i), Section 27]
Fact of the Case:
The petitioners, directors and manager of a pharmaceutical company, sought to quash a proceeding charging them with violating the Drugs and Cosmetics Act. The company had received a letter alleging non-standard quality of a drug and was subsequently charged for violation of specific provisions of the Act.
Finding of the Court:
The court found that the drug in question was within the specified limit and that the process of issuing process against the petitioners did not comply with the mandatory provision of Section 202 of the Cr.P.C.
Issues: Violation of Drugs and Cosmetics Act, compliance with standard quality, and procedural irregularities under Section 202 of the Cr.P.C.
Ratio Decidendi: The court cited precedents to support its findings, emphasizing the mandatory nature of Section 202 of the Cr.P.C. and the need for strict compliance with statutory provisions.
Final Decision: The court quashed the proceeding pending before the Metropolitan Magistrate, Calcutta, in favor of the petitioners.
JUDGMENT
Bibek Chaudhuri, J. - 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 Section 18(a)(i) and Section 27 of the Drugs and Cosmetics Act, 1940 and all orders passed in the aforesaid complaint case including order dated 28th January, 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.,
(i) Conceptualization of a drug leading to formulation and/or preparation of analytical method, validation of protocol cum report.
(ii) Disclosure of the formulae and the process through which a drug is to be made.
(iii) Formulation standard operating procedure for every batch which will be manufactured followed by a certificate of analyses for every batch.
(iv) Preparation of finished products specification reports, testing and verification by the quality control team of the company.
(v) Finalization of all such records.
(vi) Procurement of drug license from the State Drug Controller/licensing authority and lastly,
(vii) Preparation of stability study report by the quality control team after the drug is released in the market.
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 1st December 2015 to 11th February, 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.
4. It is alleged by the petitioners that the company received a letter dated 2nd April, 2018 from the office of the Drug Inspector, CDSCO (East Zone) Kolkata wherein the petitioner/company was directed to show cause and also to stop manufacturing and distribution of 'Ashycloflam P', on the ground that the drug was reported to be of non-standard quality with respect to batch number CPAO 610026 manufactured by the petition
