Madhya Pradesh High Court
M/S Aran Pharmacitucals Through ... vs Union Of India on 6 May, 2024
Author: Vivek Rusia
Bench: Vivek Rusia
(1)
IN THE HIGH COURT OF MADHYA PRADESH,
AT GWALIOR
WRIT PETITION NO. 18629 of 2023
BETWEEN :-
M/S ARAN PHARMACITUCALS THROUGH
PROPRIETOR MR. RAM NIWAS AGARWAL, S/O LATE
SHRI B.L.AGARWAL, AGED ABOUT 50 YEARS, R/O
RAMKALA NAGAR MORAR GWALIOR (MADHYA
PRADESH)
.....PETITIONER
(BY SHRI NITIN SHRIVASTAVA - ADVOCATE)
AND
1. UNION OF INDIA THROUGH ITS SECRETARY
MINISTRY OF HEALTH AND FAMILY WELFARE,
NIRMAN BHAWAN, MAULANA AZAD ROAD, NEW
DELHI
2. DRUG CONTROLLER GENERAL OF INDIA,
DIRECTORATE GENERAL OF HEALTH SERVICES,
CENTRAL DRUGS STANDE CONTROL
ORGANIZATION, MINISTRY OF HEALTH AND FAMILY
WELFARE, FDA BHAVAN, ITO KOTLA ROAD, NEW
DELHI
.....RESPONDENTS
(BY SHRI PRAVEEN NEWASKAR - DEPUTY SOLICITOR
GENERAL)
----------------------------------------------------------------------------------------
This petition coming on for admission this day, Hon'ble Shri
Justice Vivek Rusia pronounced the following:
(2)
ORDER
Petitioner has filed the present petition, under Article 226 of the
Constitution of India, seeking quashment of notification S.O. 2398(E)
dated 2/6/2023 (Annexure P/1) and also seeking writ in the nature of
mandamus commanding the respondents to withdraw the impugned
notification. By way of interim relief, petitioner is seeking permission to
sale the drugs which are already in the distribution channel.
2. Learned counsel for the petitioner submits that in similar facts and
circumstances, a co-ordinate Division Bench of this Court at Indore in
W.P. No.14982 of 2023, by way of interim relief, has granted permission
to sell the stock lying at the factory, which had been manufactured on or
before 2nd June, 2023. The petitioner is also ready to give undertaking
about further manufacturing drugs fixed dose combination of
Cholrpheniramine Maleate + Codeine Syrup (Subject Fixed Dose
Combination/Subject FDC) under the brand name of Rankuf Syrup
pursuant to notification dated 2/6/2023.
3. Learned counsel appearing for the respondents submits that
petitioner cannot be permitted to sale the drug, which is prohibited.
Petitioner is a pharmaceutical company engaged in the production of
various medicinal drugs including fixed dose combination (FDC) of
Chlorpheniramine Maleate + Codeine Syrup under the brand name of
Rankuf Syrup since 2017. Vide notification dated 2/6/2023, in exercise
of powers conferred under section 26A of the Drug and Cosmetic Act,
1940, the Central Government has prohibited the manufacture for sale,
sale or distribution for human use of drug fixed dose combination of
Chlopheniramine Maleate + Codeine Syrup with immediate effect. The
aforesaid notification has been issued in compliance of the judgment
dated 15/12/2017 passed by the Apex Court in the case of Union of India
Vs. Pfizer Ltd. and Others (Civil Appeal No. 22792 of 2017).
Therefore, this Court lacks jurisdiction to examine the validity of the
aforesaid notification.
4. So far as the grant of interim relief to sell the manufactured syrup
is concerned, there is no such final relief to this effect in this petition.
After sell of manufactured drug/syrup, the petitioner will lose interest in
this petition and the purpose of filing the petition would be served as the
validity of the impugned notification is not assailable. The syrup which is
not suitable for human consumption, cannot be permitted to be sold in
open market. Petitioner filed this petition in the month of July, 2023
which came up for hearing on 3/8/2023 and petitioner sought time to
address this Court on the question of jurisdiction. Now, more than 9
months have passed. Therefore, after nine months no permission can be
granted for sale of manufactured drug/syrup.
The petition, accordingly, stands dismissed.
(VIVEK RUSIA) (RAJENDRA KUMAR VANI)
JUDGE JUDGE
(and)
