COLOPLAST INDIA PRIVATE LIMITED vs UNION OF INDIA & ANR.
$~34
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ LPA 765/2024, CM APPL. 45324/2024 & CM APPL. 45325/2024 COLOPLAST INDIA PRIVATE LIMITED …..Appellant
Through: Mr. R. Jawahar Lal and Ms. Meghna Kumar, Advocates
versus
UNION OF INDIA & ANR …..Respondents
Through: Mr. Anurag Ahluwalia, CGSC with Mr. Shivam Sachdeva (GP), Ms. Avshreya Pratap Rudy and Ms. Francita Mary, Advocates
% Date of Decision: 08th August, 2024
CORAM: HON’BLE THE ACTING CHIEF JUSTICE HON’BLE MR. JUSTICE TUSHAR RAO GEDELA
JUDGMENT
MANMOHAN, ACJ: (ORAL)
1.
Present appeal has been filed challenging the impugned judgment dated 2nd July, 2024 passed by the learned Single Judge in W.P.(C) 6292/2022, whereby the writ petition filed by the Appellant seeking declaration that Surgical Bandages/Dressings do not fall within the scope of regulation/monitoring under Para 20 of the Drug Price Control Order, 2013 (DPCO), was dismissed in light of judgment of the Supreme Court in
Chimanlal Jagjivan Das Sheth vs. State of Maharashtra, AIR 1963 SC 665, wherein the Apex Court held that surgical dressings would come under the purview of Drugs under the Drugs & Cosmetics Act, 1940 (D&C Act).
2.
Learned counsel for the Appellant states that the National Pharmaceutical Pricing Authority (NPPA) does not have the power to monitor and initiate action in respect of Surgical Dressings under Para 20 of the DPCO before 1st April, 2020, as only after 1st April, 2020, were all medical devices notified as Drugs within the meaning of Section 3(b)(iv) of the D&C Act. He thus states that the learned Single Judge incorrectly held that Surgical Dressings were always covered under the definition of Section 3(b)(iv) of the D&C Act as Devices and hence, they fall within the scope of Para 20 of the DPCO.
3.
He submits that the Chimanlal judgment (supra) was rendered on 26th September, 1963, when Section 3(b) of the D&C Act contained only two sub-Clauses i.e. Section 3(b)(i) and (ii). He states that based on the unamended definition of Drugs under Section 3(b) the D&C Act, the Supreme Court held that the expression substances used in Section 3(b)(i) of the D&C Act, would include things intended to be used for or in the treatment and thus Surgical Dressing would fall within the scope of the definition of drugs. He states that post 1983, were sub-sections (iii) and
(iv) inserted. In this light, he submits that Surgical Dressings could not continue to be covered under the definition of Drugs under Section 3(b)(i) of the D&C Act and thus the reliance upon the Chimanlal judgement (supra) was incorrect.
4.
He states that in terms of the amended definition (Section 3(b)(iv) of the D&C Act), Device would fall within the ambit of the definition of Drugs, subject to the pre-condition that Respondent No. 1 ought to issue a Notification in the Gazette of India, prior to bringing any device within the definition of Drugs.
5.
He relies upon Office Order dated 9th July, 2014 issued by CDSCO, which unequivocally stated that other than the 14 notified medical devices (listed in the Office Order), other devices (non-notified medical devices), would not require any registration, license, permission or NOC for their import or manufacture, sale and distribution under the D&C Act. He states that Surgical Dressing was not one of the 14 notified medical devices notified as a Drugs in the aforesaid Office Order dated 9th July, 2014.
6.
Having perused the paper book, this Court finds that the issue as to whether surgical dressings would be covered under the definition of Drugs or not, came up for consideration before the Apex Court in Chimanlal (supra), wherein the Apex Court held that absorbent cotton wool, roller bandages and gauze are substances within the meaning of Drugs under Section 3(b)(i) of the D&C Act.
7.
Admittedly, Section 3(b)(i) of the D&C Act has not been amended thereafter. Consequently, surgical dressings would continue to be covered under Section 3(b)(i) of the D&C Act as well as under Paragraph No.20 of the DPCO.
8.
At this stage, learned counsel for the appellant states that though the learned Single Judge has clarified that the mode of calculation of charges
would be in accordance with the judgment of this Court in Union of India and Another v. Bharat Serums and Vaccines Limited, 2023 SCC OnLine Del 7262, yet it has not remanded the matter to NPPA.
9.
We find merit in the said submission. Accordingly, the matter is remanded to NPPA restricted to re-computation/re-calculation of charges in accordance with the judgment of this Court in Bharat Serums (supra).
10.
With the aforesaid directions, the appeal stands disposed of.
ACTING CHIEF JUSTICE
TUSHAR RAO GEDELA, J
AUGUST 8, 2024
Aj