JUDGMENT :

T.S. SIVAGNANAM, J.

1. Both these intra-Court appeals have been filed by the writ petitioner, MAT No. 296 of 2023 is against an interim order passed in the writ petition on 6th February, 2023 and MAT No. 669 of 2023 is challenging the order dated 21st March, 2023 by which writ petition was dismissed. The appellant filed the writ petition challenging a notice issued by the respondent, the Health Services Department of West Bengal dated 09.12.2022 and the email communication dated 15.12.2022 pertaining to the notice of e-tender for procurement of gloves by the Department. The petitioner also sought for issuance of a writ of mandamus to forbear the respondents from giving effect to the circular dated 30th September, 2022 issued by the Drug Controller General of India issuing certain guidelines with regard to the license to be obtained from the Central Licensing Authority or the State Licensing Authority.

2. The first appellant is a company registered under the Companies Act having its registered office at Cochin, Kerala State and the second respondent is its Director. The appellant company is engaged in the manufacture of latex surgical gloves which fall under Class B Medical Devices that is low moderate risk category. The Medical Devices Rules, 2017 was notified on 31st January, 2017. In terms of Rule 8 of the said Rules, the State Dugs Controller shall be the State Licensing Authority designated as the competent authority for enforcement of the 2017 Rules, inter alia, in relation to manufacture for sale and distribution of Class A or Class B medical devices. By notification dated 11th February, 2020, the Ministry of Health and Family Welfare Department notified the Medical Devices Amendment Rules, 2020 and Rule 19 A was inserted. In terms of Sub-rule (1) of Rule 19A Chapter IIIA captioned “Registration of Certain Medical Devices” was made applicable to all devices notified under Clause b of Section 3 of the Act except the medical devices and devices specified in the annexure of the each schedule of the said Rules. In terms of Sub-rule (2), the medical devices referred in Sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Association for this purpose. The proviso states that the registration under Chapter IIIA shall be of voluntary basis for a period of 18 months from the commencement of the said Chapter and thereafter it shall be mandatory as specified in the proviso contained in second column of the Serial No. 7 as inserted by the Rule 3 of the 2020 Amendment which states that such exemption shall cease after a period of 30 months for low risk Class A and low moderate risk Class B and after a period of 42 months for moderate high risk Class C and high risk Class D devices respectively from the date of the notification of the Rules. During August-September, 2022 various associations and stakeholders submitted representations with the Central Drugs Control Organization requesting not to disrupt the business operations of the manufacturers and suppliers. By circular dated 30th September, 2022 published on 20:41:38 hours, it was made known that if an existing importer/manufacturer is already importing/manufacturing any Class A or Class B medical devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30th September, 2022, as the case may be, for grant of import/manufacturing license in respect of the said devices under the provisions of the 2017 Rules, the said application shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said devices upto 6 months from the date of issue of the circular or till the time the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier. The appellant’s case is that the circular was published around 8:41 P.M. on 30th Se