IN THE HIGH COURT OF HIMACHAL PRADESH AT SHIMLA
AJAY MOHAN GOEL, J.
Aniketh Jain – Petitioner
Versus
State of Himachal Pradesh and Another – Respondents
CWP No. 4391 of 2023
Decided On : 22-12-2023
Drugs Manufacturing License - Drugs and Cosmetics Act, 1940 - Section 3, Section 18, Rule 79 of the Drugs and Cosmetics Rules, 1945
Fact of the Case:
The petitioner applied for a drugs manufacturing license, which was rejected based on the premises' history and pending complaints. The petitioner appealed, arguing that the rejection was arbitrary and not in accordance with the procedure laid down in Rule 79 of the Drugs and Cosmetics Rules, 1945.
Finding of the Court:
The court found that the rejection of the application was not based on fulfilling the conditions provided under Rule 79, but on extraneous grounds related to pending complaints and an FIR. The court held that the rejection was bad in law and directed the Licensing Authority to proceed with the application afresh in accordance with Rule 79.
Issues: The issues revolved around the rejection of the drugs manufacturing license application and the compliance with Rule 79 of the Drugs and Cosmetics Rules, 1945.
Ratio Decidendi: The rejection of a drugs manufacturing license application should be based on fulfilling the statutory conditions and in accordance with Rule 79 of the Drugs and Cosmetics Rules, 1945, rather than extraneous grounds.
Final Decision: The petition was allowed, and the impugned orders were set aside. The Licensing Authority was directed to proceed with the application afresh in accordance with Rule 79.
JUDGMENT :
AJAY MOHAN GOEL, J.
1. By way of this writ petition, the petitioner has prayed for quashing of order dated 16.04.2022, passed by Assistant Drug Controller-cum-Licensing Authority, Baddi, District Solan, H.P. in terms whereof, an application submitted by the present petitioner for grant of Drugs Manufacturing license was rejected, as also the order passed by the learned Appellate Authority-cum-Principal Secretary (Health), to the Government of Himachal Pradesh, under the Drugs and Cosmetics Act, 1940 and Rules framed there under, in terms whereof, the appeal filed by the present petitioner against the order passed by Assistant Drug Controller-cum-Licensing Authority, was dismissed.
2. The case of the petitioner is that he has established a Unit in Plot No. 32, Industrial Area, Kala Amb, District Sirmaur, Himachal Pradesh, in the name and style of Dutch Formulations for the purpose of manufacturing drugs under the Drugs and Cosmetics Act, 1940. He applied for grant of drugs manufacturing licence after complying with all the codal formalities.
3. Respondent No. 2 rejected the application of the petitioner on the grounds that the petitioner had applied for grant of drugs manufacturing licence in the premises situated at Plot No. 32, Industrial Area, Kala Amb, District Sirmour, H.P. where previously a firm in the name and style of M/s Vardhman Pharma was running, which was raided by the Drugs Control Department of Himachal Pradesh for manufacturing of spurious drugs and two complaints filed against it were still pending in the High Court and a letter from SHO, Police Station, Kala Amb, was received by respondent No. 2, with respect to FIR No. 24/2022, dated 25.02.2022, under Sections 420, 467, 468 and 471 of the Indian Penal Code, informing that the same was still under investigation.
4. Feeling aggrieved, the petitioner preferred a statutory appeal before the Appellate Authority. The Appellate Authority dismissed the appeal of the petitioner by affirming the findings returned by the 2nd respondent, hence the petition.
5. Learned Senior Counsel appearing for the petitioner has argued that the orders passed by the 2nd respondent as well as the Appellate Authority are perverse as while rejecting the application filed by the petitioner both the authorities erred in not appreciating that the application of the petitioner was required to be processed in accordance with the procedure laid down in Rule 79 of the Drugs and Cosmetics Rules, 1945, whereas the application of the petitioner stood rejected by respondent No. 2 on grounds totally extraneous, which had got nothing to do with the scheme of the Rule and Appellate Authority also, without any due application of mind, upheld the said order without realizing that the application of the petitioner was rejected in a completely arbitrary manner by taking into consideration extraneous facts which could not have been taken into consideration. Accordingly, he has prayed that the petition be allowed, impugned orders be set aside and a direction be issued to the respondents to issue a manufacturing licence in favour of the petitioner.
6. Learned Law Officer, while defending the act of the respondents, has submitted that as it is clearly borne out from the record that there were two criminal cases still pending against the manufacturing Unit, which was previously manufacturing medicine on the plot wherein the petitioner has set up his Unit and further as it was a matter of record that there was an FIR registered against the petitioner, pending investigation, therefore, there is no infirmity in the impugned order and for these reasons, the present petition is liable to be dismissed.
7. I have heard learned Senior Counsel appearing for the petitioner as well as learned Law officer. I have also carefully gone through the order passed by respondent No. 2 as well as learned Appellate Authority and also documents appended with the petition as well as relevant provisions of the Drugs and Cosmetics A
The central legal point established in the judgment is the exemption of the drugs manufactured by the petitioner from the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940 under Schedule ....
The cancellation of a drug licence is invalid if the sampling procedure is not followed as mandated by law, and if the show cause notice lacks clarity regarding allegations.
Administrative decisions regarding license cancellations must be reasoned and adhere to statutory provisions to avoid arbitrariness.
Manufacturing bleaching powder not intended for medicinal use is exempt from licensing under the Drugs and Cosmetics Act, 1940.
Seizure of adulterated and spurious drugs – Former Director of Company has no criminal liability.
The appellate authority under the Drugs and Cosmetics Act lacks jurisdiction to review its own order without statutory provision, becoming functus officio after a final decision.
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