IMPORTANT POINT
The judgment underscores the necessity of adhering to procedural requirements in drug quality cases, particularly the timely filing of complaints and the rights of manufacturers to contest lab findings.

ORDER :

G. Jayachandran, J.

The petitioners herein are M/s Gopal Life Sciences, Solan, Himachala Pradesh, its Partner and Authorised Signatory-cum-Manager.

2. A complaint by the Drug Inspector, Vellore Zone under Section 32 of The Drugs and Cosmetics Act, 1940(hereinafter referred to “the Act”), for contravention of Section 18(a)(i) and punishable under Section 27(d) of the said Act laid before the Judicial Magistrate, Chengam, Tiruvannamalai District and taken on file as S.T.C.No.183 of 2022.

3. The gist of the complaint is that, on 30/07/2019, a sample of 4x100ml TERBOT-G syrup (Terbutaline sulphate, Bromhexine, Guaiphenesin and Menthol Syrup), B.No.GLL-8036, M/D:7/18, E/D:6/20, Mfd by Gopal Lifesciences, Hill top Industrial Estate, Near Export Zone, Jharmajri, Baddi (H.P)-173205(marked as 45/MSA/19/TVM-II) was drawn for analysis from M/s Vasuki Medicals situated at No.223, Nadu Street, Mothakkal Post, Tiruvannamalai-II Range, under Form-17 dated 30.07.2019 and sent for analysis to the Government Analyst under Form-18 dated 30.07.2019. The said drug has been declared as Not of Standard Quality drug by the Government Analyst, Drug Testing Laboratory, Chennai-6 for the reason that the sample does not conform to Label claim with respect to the content of Terbutaline Sulphate (70.83%) and Bromhexine Hydrochloride(68.13%), thereby for having manufactured for sale, stocked for sale and sold the said Not of Standard Quality drug, the Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 has been contravened.

4. M/s Vasuki Medicals was issued a show cause memo under Section 18-A of the Act for stock and selling the subject drug. In response, Vasuki Medicals, the seller/stockist, vide its letter dated 18/09/2019 disclosed that he purchased the drug from M/s Radha Medical Stores, Harur.

5. A show cause memo dated 20/09/2019 was issued to M/s Radha Medical Stores, Harur, to disclose the name, address and other particulars of the person from whom they had acquired the stock of the subject drug. In response to the memo, M/s Radha Medical Stores, Harur informed that they purchased the subject drug from M/s Cosmic Pharma, Trichy. To the show cause memo sent to M/s Cosmic Pharma on 15/10/2019, they replied that the subject drug was purchased from its manufacturer M/s Gopal Lifesciences (Unit II), Panchkula, Haryana under invoice No: GST/INV-1775 dated 13/11/2018 and GST /INV-1826 dated 19/11/2018.

6. Since M/s Gopal Life Sciences, Panchkula, is being the manufacturer of the subject drug, a show cause notice for contravention of Section 18(a)(i) of the Act was caused along with the copy of the test report. They were called to furnish the documents and particulars, such as, the drug licences, product endorsement, constitution details, batch manufacturing records, etc. They were also instructed to recall the subject drug from the persons to whom they sold /supplied and to furnish the details of those recalled stocks of drugs.

7. In response to the notice, the Manufacturer, M/s Gopal Life Sciences, controverted the lab result and claimed that the subject drug was delivered only after ensuring all the parameters checked and no discrepancies observed. On getting the information, they tested their control sample of subject drug and no discrepancies observed. Though they enclosed the copies of product endorsement, recall letter, invoice copy, etc., they did not enclose the required documents such as constitution details, drug licences, Batch Manufacturing records, etc., Since, the reply of the Manufacturer was not satisfactory, after getting sanction from the Director of Drugs Control on 11/06/2020, the complaint was lodged.

8. The Learned counsel for the petitioners contended that the complaint is liable to be quashed on the ground that the complainant failed to forward the third sample to the Manufacturer along with the show cause memo. Though in the complaint it is stated that the third sample was sent to the manufacturer through registered post separate