Himachal Pradesh High Court
Court On Its Own Motion vs . State Of H.P. & Others on 5 November, 2024
Author: Tarlok Singh Chauhan
Bench: Tarlok Singh Chauhan
Court on its own motion vs. State of H.P. & Others a/w connected matters.
CWPIL No. 30 of 2023, CWPIL No. 83 of 2022 & CWP No. 3118 of 2023 CWPIL No. 30 of 2023 05.11.2024 Present: Court on its own motion.
Mr. Anup Rattan, Advocate General, with Mr. Rakesh Dhaulta, Additional Advocate General, for respondents No. 1 to 5/State.
Mr. Anuj Nag, Advocate, for respondent No.6. CWPIL No. 83 of 2022 Court on its own motion.
Mr. Anup Rattan, Advocate General, with Mr. Rakesh Dhaulta, Additional Advocate General, for the respondents/State.
CWP No. 3118 of 2023 Mr. Rajneesh Maniktala, Sr. Advocate, with Mr. Dinkar Bhaskar, Advocate, for the petitioner.
Mr. Balram Sharma, Deputy Solicitor General of India with Mr. Rajeev Sharma, Advocate, for respondents No. 1 and 2.
Mr. Anup Rattan, Advocate General, with Mr. Rakesh Dhaulta, Additional Advocate General, for respondents No. 3 and 4/State.
Mr. Manish Kapoor, Deputy Drug Controller at Baddi and Mr. Rakesh Negi, Drugs Inspector, Central Drugs Standard Control Organization (CDSCO), Baddi Zone, are present in person.
State of Himachal Pradesh is one of the major hubs of Pharmaceutical Manufacturing Units in Asia with more than six hundred Manufacturing Pharmaceutical Units. Repeated failure of samples of drugs manufactured in the State is disparagingly disturbing feature, therefore, in the larger public interest, this Court has been called upon to adjudicate upon the relevant issues by way of these PILs.
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2. The stake holders have provided various inputs during the proceedings of these petitions. Keeping such contributions in view, we find it necessary to make following observations at this stage: -
(a) (i) Every person, having natural or legal entity, holding license to manufacture drugs is under legal duty to provide and maintain staff, premises and equipment as specified in Rule 71 of the Drugs Rules, 1945 (for short, "The Rules"). Sub Rule 4 and 4(a) of Rule 71 of the Rules provides as under:
"(4). The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at the testing unit which shall be separate from the manufacturing unit and head of the testing unit shall be independent of the head of the manufacturing unit:
Provided that the manufacturing units, which, before the commencement of the Drugs and Cosmetics (Amendment) Rules, 1977, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf may continue such arrangements up to the 30th June, 1977:
Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the licensing authority may permit such tests to be conducted by institutions approved by it.
(4A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate."
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(a) (ii) Sub Rule 7 of Rule 71 further obligates the licensee to comply with the requirements of 'Good Manufacturing Practices' as laid down in Schedule M of the Rules.
(a) (iii) Rule 74 (c) mandates the licensee to either test each batch or lot of the raw material used by him for manufacture of his products and each batch of the final product in his own laboratory or in any other laboratory approved by the licensing authority and further to maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The particulars to be shown in manufacturing records under Schedule U are required to be authenticated by the signature of the examiner.
(a) (iv) We have noticed from the formats prepared in compliance to Rule 74 (a) and (c) coupled with Schedule U appended to the Rules that the provision for identity of examiner of the tests conducted in the inhouse laboratories is vague. Such identification needs to be clear and unambiguous and for such purpose complete particulars as to the name of the examiner and his identification by the registration number allotted to him by the concerned Pharmacy Council are required to be incorporated. The State Drug Authority/ licensing authority can additionally maintain register of such examiners employed by the manufacturing units of drugs in the State and the registration number allotted by the State Drug Authority also needs to be mentioned in the format. In computer generated certificate of analysis, the requirement of digital signatures of
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the examiner also needs to be mandated.
(b) (i) As per Rule 74 (c) of the Rules, a manufacturer of drugs (licensee) is mandated to get each batch or lot of the raw material and also the final product tested either in his own laboratory or in any other laboratory approved by the licensing authority. This provides an unfettered discretion with the licensee to get the tests in his own laboratory. We prima-facie find that there are no sufficient regulatory provisions to certify the authenticity of tests conducted in the inhouse laboratories of the licensees. In our considered view, the testing of the raw material as also the final product should be mandated either by the Government laboratories or the laboratories approved by the Drug Authority.
(b) (ii). Learned Senior Advocate Mr. Rajneesh Maniktala has contended that the word 'or' used in Rule 74 (c) of the Rules, which provides discretion with the licensee to get the test conducted either in the inhouse laboratory or laboratory approved by the licensing authority, is required to be read as 'and' in order to make the provision of said Rule effective. We defer the consideration on the issue till the submission of response by the respondents as directed hereafter.
(b) (iii) It has also been noticed that neither inhouse laboratories of the licensees nor the laboratories approved by the Drug Authorities are required to be accredited by the National Accreditation Board for Testing and Calibration Laboratories (for short NABL). This makes the test procedures
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(c) (i) The Ministry of Health and Family Welfare, Government of India vide notification dated 17.11.2022, has amended the Rules. In Rule 96 sub-rule 6 has been added whereby the manufacturers of drug formulation products as specified in Schedule H2 has been mandated to print or affix the Bar Code or Quick Response Code (QR Code) on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that stores data or information decipherable with software application to facilitate authentication. The stored data or information referred to in newly added sub-rule (6) mandates inclusion of the following particulars namely: -
(i) unique product identification code;
(ii) proper and generic name of the drug;
(iii) brand name;
(iv) name and address of the manufacturer;
(v) batch number; (vi) date of manufacturing; (vii) date of expiry; and
(viii) manufacturing licence number".
(c) (ii) The above amendment indisputably is a progressive step to facilitate the objective behind Drugs and Cosmetics Act and the Rules framed thereunder. Since, the purpose is to make available the necessary information regarding authenticity
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of drug to the public, it is advisable that the stored data is made available to the consumer or any other person in a user friendly mode, which, in our considered view, can be made compulsorily through Quick Response Code in addition to other modes as the QR Code is easily decipherable with the help of applications available in the smart mobile phones commonly owned by the public at large.
(c ) (iii) We have not come across any reason as to why Rule 96 of the Rules has been amended in respect of Schedule H2 drugs only. In our view, the above amended provision can be extended to all kinds of drugs.
3. We direct the respondents to file their respective affidavits in response to the above observations made by us on or before the next date of hearing.
4. We have also come across the factum of comprehensive examination of drug regulatory issues at the national level undertaken by 'Mashelkar Committee'. We further direct respondents No. 1 and 2 in CWP No. 3118 of 2023, to produce on record a copy of the report of 'Mashelkar Committee' on or before the next date of hearing.
List on 19.11.2024.
(Tarlok Singh Chauhan)
Acting Chief Justice
5th November, 2024 (Satyen Vaidya)
(GR) Judge