60-Day Deadline for Drug Testing is Mandatory; Delays Help Sub-standard Manufacturers: Bombay High Court

Nagpur: The Nagpur Bench of the Bombay High Court has sent a strong message to the Food and Drugs Administration (FDA) regarding the safety of medicines in India. The Court ruled that the 60-day limit for testing drug samples is not just a suggestion but a mandatory requirement.

In a significant judgment, Justice M.M. Nerlikar observed that systemic delays by government officers in testing medicines not only ruin legal cases against offenders but also put the lives of the general public at risk by allowing "not of standard quality" drugs to circulate in the market.

The Court was hearing a petition filed by Mr. Ashwani Lamba and other directors of M/s Oscar Remedies Pvt. Ltd. The petitioners sought to quash a criminal case pending against them in Gadchiroli.

The case began on July 12, 2022, when a Drug Inspector visited a medical shop and took samples of a capsule named RTZOL-DSR. These samples were sent to the Government Analyst for testing on July 14, 2022.

Under the law, the report should have been ready within 60 days. However, in this case:

1. The 60-day period expired in September 2022.
2. The Government Analyst asked for an extension only on November 1, 2022 (after the deadline had already passed).
3. The final report, declaring the drug "not of standard quality," was only received on January 18, 2023.
4. The manufacturer was notified of this failure only in April 2023—nearly four months after the report was ready.

The petitioners argued that according to Rule 45 of the Drugs and Cosmetics Rules, 1945, the Government Analyst must furnish a report within 60 days. If they cannot meet this deadline, they must seek an extension before the time expires, giving specific reasons.

The Court agreed with the petitioners. It noted that the quality of drugs can change over time. If a sample is tested much later than required, the results might not be accurate. More importantly, a delay prevents the accused from exercising their legal right to have the sample re-tested by a different laboratory to prove their innocence.

Justice Nerlikar expressed "surprise" at the leniency shown by the authorities. The Court remarked that when officers sit idle and ignore strict timelines, they essentially help the manufacturers of sub-standard drugs.

"The lapses on the part of the Drug department would be beneficial to the manufacturers who are manufacturing the sub-standard drugs... these drugs are adversely affecting human beings on a large scale," the Court stated.

The Court emphasized that the primary goal of the Drugs and Cosmetics Act, 1940 is to ensure the safety and efficacy of medicines. When officers fail to follow procedures, they frustrate the very purpose of the law.

While quashing the criminal proceedings against the petitioners, the High Court issued a set of mandatory directions to the Commissioner of Food and Drugs Administration (FDA), Maharashtra, to ensure this doesn't happen again:

1. Strict Timelines: Ensure that all drug sample reports are received within the 60-day period as per Rule 45.
2. Accountability: Take strict disciplinary action against any officer who fails to comply with the Act or the Rules.
3. Infrastructure Expansion: If the delay is due to "heavy workload," the Commissioner must ask the Government to build more laboratories.
4. Real-Time Online System: The Court ordered the creation of an efficient online system where the status of drug samples and test reports can be tracked on a real-time basis.
5. Public Transparency: The entire process should ideally be web-hosted so that everyone involved knows the outcome of the testing.
6. Prompt Extensions: Government Analysts must seek extensions immediately and in writing if they cannot meet the deadline, and the Government must respond to these requests promptly.

The High Court concluded that since the rules were not followed, the prosecution could not be allowed to continue. However, it made it clear that the FDA must fix its "broken system." The Court has ordered the FDA Commissioner to report back on the progress of these changes by May 4, 2026.

This judgment serves as a vital reminder that in matters of public health and medicine, time is of the essence. Procedural delays by the state are not just "paperwork errors"—they are safety risks that the law will no longer tolerate.

Case Details:

1. Case Title: Ashwani & Ors. v. State of Maharashtra
2. Case Number: Criminal Writ Petition No. 967 of 2024
3. Court: Bombay High Court (Nagpur Bench)
4. Judge: Justice M.M. Nerlikar
5. Date of Order: January 17, 2026