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2020 Supreme(Mad) 87
IN THE HIGH COURT OF JUDICATURE AT MADRAS
C.V. KARTHIKEYAN, J.
M/s. Jackson Laboratories Private Limited, A Private Limited Company Registered under The provisions of the Companies Act, 1956, Represented by its Managing Director, Jugal Kishore, Amritsar - Appellant
Versus
Secretary to Government, Health & Family Welfare (H2) Department, Secretariat, Chennai & Others - Respondent
W.P. No. 25770 of 2019 & W.M.P. No. 25218 of 2019
Decided On : 28-02-2020
For the Petitioner:P.R. Raman, Senior Counsel for P. Ramesh Kumar, Advocate. For the Respondents:R1, R. Govindasamy, Special Government Pleader, R2 to R4, Shivakumar, Advocate.
Headnote:
Drugs and Cosmetics Act - Pharmaceutical Manufacturing - Section 17, 17A, 17B, 18, 20, 21, 22, 23, 25 - The court examined the case of M/s. Jackson Laboratories Private Limited, Amritsar, Punjab, which was blacklisted for supplying spurious drugs. The court found that the drugs supplied were not of standard quality and banned the specific drug, Carbimazole Tablets IP 5 mg, for 5 years. The court upheld the blacklisting of the company for supplying spurious drugs and dismissed the appeal.
Fact of the Case:
M/s. Jackson Laboratories Private Limited participated in a tender to supply pharmaceutical drugs. The drugs supplied were found to be not of standard quality and spurious. The company was blacklisted for 5 years.
Finding of the Court:
The court found that the drugs supplied were not of standard quality and banned the specific drug, Carbimazole Tablets IP 5 mg, for 5 years. The court upheld the blacklisting of the company for supplying spurious drugs and dismissed the appeal.
Issues: Quality of drugs supplied, compliance with tender conditions, and procedural violations.
Ratio Decidendi: The court upheld the blacklisting of the company for supplying spurious drugs and dismissed the appeal. The specific drug, Carbimazole Tablets IP 5 mg, was banned for 5 years.
Final Decision: The Writ Petition was partly allowed, setting aside the blacklisting of the company for 5 years but banning the specific drug, Carbimazole Tablets IP 5 mg, for 5 years.
JUDGMENT
(Prayer :Petition filed under Article 226 of the Constitution of India praying to issue a Writ of Certiorari, calling for the records on the file of the 1st respondent in issuing Letter No.46953/H2/2017-6 dated 26.06.2019, and quash the same.)
1. This Writ Petition has been filed by M/s. Jackson Laboratories Private Limited, Amritsar, Punjab, in the nature of Writ of Certiorari, calling for the records on the file of the 1st respondent, namely, the Secretary to Government, Health and Family Welfare (H2) Department, Chennai, with respect to letter No.46953/H2/2017-6 dated 26.06.2019 and quash the same.
2. In the affidavit filed in support of the writ petition, it had been stated by the Managing Director of the Petitioner company, that the petitioner is a licensed Pharmaceutical manufacturing unit based in Amritsar, Punjab, and engaged in the business of manufacturing pharmaceuticals drugs. It had been claimed that the petitioner has been awarded ISO 9001:2008 Certification for excellence in Total Quality Management. The petitioner has also been awarded the Quality Vendor Certification by the Director General Quality Assurance, New Delhi. It has been claimed that the petitioner has installed the latest technology machinery for production and packaging of pharmaceutical drugs. The petitioner also claimed that they have been provided with Good Laboratory Practices Certificate.
3. It had been further stated that the petitioner participated in the Tender No.002/M(P) DRUG/TNMSC/2017 dated 16.06.2017 floated by 4th respondent namely, the General Manager (Drugs), Tamil Nadu Medical Services Corporation Ltd., (TNMSC) Chennai, for supply of various medicines. The bid submitted by the petitioner was accepted with respect to a number of products, where they were the lowest bidder. The 4th respondent directed the petitioner to submit an agreement to supply various items at the quoted rates. An agreement was also submitted by the petitioner on 22.11.2017. It was stated that the petitioner was awarded one product (Tab. Carbimazole 5 mg) with specifications as 'Coated Tablets' in packing of blister strips.
4. The petitioner addressed the 3rd and 4th respondents namely, the Managing Director of Tamil Nadu Medical Services Corporation Ltd., and the General Manager (Drugs) of Tamil Nadu Medical Services Corporation Ltd., that this tablet is usually supplied as loose Uncoated Tablets in a bottle pack. But the petitioner was still asked to supply the said tablets as Coated Tablets in blister packs. The petitioner then supplied a large quantity of this product throughout Tamil Nadu. In accordance with the statutory resolutions, the drug was tested by the 3rd and 4th respondents. It was found to be of Standard Quality. It was claimed that after sometime a different Drug Inspector tested the samples from different hospitals. One such sample was tested by Dr.S.Gopinath, Drugs Inspector, CDSCO, South Zone, Chennai, from the premises of the warehouse K.K.Nagar. On testing, the Government Analyst declared 'Nil' content. It was claimed that the Drugs Inspector also visited the factory and made detailed enquiry. It was claimed that the drug is light sensitive and thermolible drug and is required to be stored below 300C whereas the temperature in Chennai crosses 450C. It was stated that the date of sampling was on 23.05.2017, the date of receipt in Laboratory was on 26.05.2017, the date of Testing was between 12.07.2017 and 20.07.2017 and the date of report was 11.08.2017.
5. The petitioner claimed that the defects had come due to improper storage. It was stated that on the basis of the report, the 3rd respondent took cognizance without sending the report to the petitioner. The petitioner received a show cause notice dated 15.07.2017 from the 4th respondent stating that the Tablet Carbimazole Batch No.12701 had been reported to be 'Not of Standard Quality' and explanation was sought why the product should not be blacklisted for two years. The petitioner c
