Section 18A of Drugs and Cosmetics Act requires disclosure of name of manufacturer not just dealers: Rajasthan High Court

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The High Court of Rajasthan observed that Section 18A of the Drugs and Cosmetics Act 1940 requires the disclosure of the name of the manufacturer also and not just the dealers and hence he is entitled to receive a sample of part of the drugs seized under section 23(4) of the Act.

Section 18A of the Act deals with the disclosure of the name of the manufacturer, etc. “Any person who is not the manufacturer of a drug or cosmetic or his agent for the distribution thereof shall, if required to do so, disclose to the inspector the name, address and other details of the person from whom it acquired the drug or cosmetic.”.

Article 23(4) r/e 23(3) provides that when an inspector takes a sample of a drug for the purpose of testing or analysis, he must divide the sample into four portions and return one portion to the person from whom he takes it and retain the rest.

Essentially, the Drug Inspector sent a notice to the Claimant stating that certain drugs, which were manufactured by the Claimant, were seized from the CHC Drug Store, Kota, which in turn were purchased from the Drug Store of the district, Kota. According to the notice, the drugs were not of standard quality.

The petitioner filed a request with the Chief Judicial Magistrate to provide part of the drug sample out of the total of four samples to be prepared under the provisions of section 23(3) of the Act.

The Chief Judicial Magistrate refused this prayer stating that part of the sample had already been provided to the District Drug Warehouse Warden, therefore, there is substantial compliance with the law. The hearings judge upheld the said order. The aggrieved petitioner challenged both orders in this section 226 motion.

Judge Birendra Kumarwhile granting the motion and setting aside the orders made by the two lower courts, observed,

“A plain reading of the provisions of Section 23(4)(iii) above would make it clear that part of the sample is to be sent to the person whose name and address has been disclosed under the 18A as a manufacturer. Section 18A of the law requires disclosure of the name of the manufacturer and not just the dealers.”

The court ordered that the petitioner receive part of the sample seized under the law. It was held that the two lower courts failed to exercise the jurisdiction conferred upon them, resulting in a miscarriage of justice.

Further, the court observed that under Section 18A, the name of the manufacturer must also be disclosed in addition to other information about the purchase of the drugs in question. The court held that on reading the opinion of the Inspector of Medicines it is clear that under Section 18A the name of the claimant has been disclosed as the manufacturer. Therefore, the petitioner was entitled to part of the seized sample under section 23(4)(iii) of the Act, the court added.

In this regard, the court stated that

“The notice to the petitioner reveals that the petitioner’s name has been disclosed as a manufacturer under Section 18A. Therefore, the petitioner is entitled to a sample of the drugs seized to protect/defend his rights and interests in the procedure in progress.”

Counsel for the petitioner argued that the four sets of samples should be handled in accordance with Section 23(4) of the Medicines and Cosmetics Act. He argued that it appears from the notice that the Kota District Drug Warehouse disclosed under Section 18A of the Act that the drug was purchased from the petitioner. Therefore, the law under Section 23(4)(iii) read with Section 18A of the Act, requires the petitioner to be given a set of drug samples, he argued.

Counsel for the Respondents argued that there was substantial compliance with the law as the drugs were seized at Drugs Store, CHC, Vigyan Nagar, Kota and this authority disclosed under Section 18A that he had ]obtained the drug from District Drugs Warehouse, Kota, to whom one of the samples had already been supplied. He added that the petitioner had no right anywhere to obtain a sample under the provisions of Section 23 of the Medicines and Cosmetics Act.

Case title: M/s Vivek Pharmachem (India) Ltd. vs. State of Rajasthan & Anr.

Quote: 2022 Live Law (Raj) 166

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