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| DB directs Secy Health to ensure compliance of Drugs and Cosmetics Act provisions | | | Early Times Report
JAMMU, July 25: In a Public Interest Litigation (PIL) filed by Indigenous Medicines Organization, a Division Bench of J&K High Court comprising Chief Justice Gita Mittal and Justice Sanjay Dhar directed Principal Secretary Health and Medical Education to ensure compliance of all the provisions of Drugs and Cosmetics Act, 1945 and the Drugs and Cosmetics Rules, 1945 including Rule 158-B of the Drugs and Cosmetics Rules, 1945 in the Union Territory of Jammu and Kashmir.
In the PIL it was submitted that that Ministry of Health and Family Welfare (Department of AYUSH) issued a notification dated 10.08.2010 vide No. G.S.R. 663 (E) pursuant to objections and suggestion as per earlier notification dated 3rd of May, 2010 framed Drugs and Cosmetic (6th Amendment) rules 2010 which have been directed to come into force from the date of their publication in the Official Gazette in exercise of power conferred on Central Government by Section 33-N of the Drugs and Cosmetics Act, 1945. In view of the amendment above referred brought by the then Ministry of Health and Family Welfare now AYUSH, Rule 158 (B) was enacted which deals with guidelines for issue of Licence with respect to Ayurveda Siddha and Unani medicines.
It is further submitted that the Ministry of “AYUSH” having failed to give practicability to the aforesaid notification and made Drugs and Cosmetic Rules by virtue of Rule 158-B came to be legislated despite of elapse of sufficient long time, that the Petitioner organization took up the matter with the Ministry of AYUSH by submitting their complaint by way of their representation on 20.11.2017.
Pursuant upon the Petitioner Organization having taken up the matter with respondent No. 1, Ministry of “AYUSH” suddenly woke up from deep slumber and came up with a letter which was addressed to all State Licensing Authorities for Ayurveda, Siddha and Unani Drugs regarding licensing requirement for Ayurveda, Siddha and Unani Drugs as per Rule 158-B of the Drugs and Cosmetic Rules 1945.
It was communicated to all State Licensing Authority of AYUSH, Siddha and Unani to carryout statutory responsibility to grant license / renewal license in accordance with the guidelines specified in the rule 158-B of the Drugs and Cosmetic rules, 1945.
It is further submitted that despite the Ministry of “AYUSH” also showing health concern of citizen by issuing letter dated 09.09.2008 and enacting Rule 158-B, further issuance of letter dated 16.09.2014 as well as 20.12.2017, but the directions issued in this regard are being violated with impunity due to lackluster concern of the Ministry as regard mandatory compliance and strict implementation of the Rules.
One such example can be seen from the latest tender issued by Directorate of AYUSH, Government of NCT Delhi wherein in continuation with tender ID No. 2019-DAYUS-172253-1 where it is provided that there is no mandatory requirement of clinical trial.
Division Bench after hearing both the sides observed that notices issued to the respondents on 18th January 2020 have not been received back so far. Subject to the petitioner’s taking steps, issue fresh notice for the service of the respondents returnable on 21st October 2020.
DB further directed that notices shall be additionally served digitally. AAG Aseem Sawhney, accepts notice who is present in video conferencing in some other matter has been requested to accept notice on behalf of the respondent No 5, the Department of Health and Medical Education.
DB further directed reply shall be filed by the respondent No 5 before the next date of hearing and respondent shall ensure compliance with all the provisions of Drugs and Cosmetics Act, 1945 and the Drugs and Cosmetics Rules, 1945 including Rule 158-B of the Drugs and Cosmetics Rules, 1945 in the Union Territory of Jammu and Kashmir. (JNF)
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