The Supreme Court recently ruled that drug inspectors can carry out an investigation and file a first information report (FIR) related to cognizable offences which is specified as under the chapter IV of the Drug and Cosmetics Act 1940. Chapter IV of the Drugs and Cosmetics Act 1940, deals with the manufacture, sale and distribution of drugs and cosmetics activities.

According to the Section 22(1)(d) of the Act, which deals with the powers of the ‘Inspector’, inter alia, enables the inspector to exercise such other powers as may be necessary for carrying out the purpose of Chapter IV or any Rules made thereunder. A police officer can register an FIR only if a cognisable offence, other than an offence falling under Chapter IV of the Act, is also made out. As far as FIRs that have already been filed are concerned, further investigation cannot be done by the Police officer.

The recent judgement of the Supreme Court concluded that for offences committed under Chapter IV of the Drugs and Cosmetics Act 1940, only the ‘Drug Inspector’ has the powers to investigate any complaint, institute prosecution and even arrest the offenders. Whereas, the police officer has absolutely no role to play in such offences. Therefore, the police are bound to provide assistance to the drug inspector in case of need, to effectuate the arrest where there is resistance or likelihood of resistance. However, drug inspectors, who carry out any arrest, need to immediately report the arrests to their superior officers.

The move is appreciated by industry experts as well regulators, but many have also expressed the need for well-defined required infrastructure, single operating procedures for implementation.

Commenting on the judgement, Narendra Ahooja, State Drug Controller, Haryana, commented, “The recent detailed judgement by the Supreme Court is a right step towards making the law very clear and transparent. In its order, it has defined that the actions under the provision of Drug and Cosmetics Act 1940 for cognizable offences needs to be taken by the drug inspector as notified under Section 21 of the Drugs and Cosmetic Act,1940. But to implement the order of the honourable Supreme Court in its true sense, the state FDAs need to be strengthened with required infrastructure and facilities.”

He added, “The drug inspector needs to be equipped with all the required infrastructure which have been given to a police inspector and other similar authorities.”

SW Deshpande, Former Joint Commissioner FDA Maharashtra and Advocate Founder of PHARMALEX, highlighted, “The Supreme Court’s order has wider implications. According to the order, it allows drug inspectors to carry out the investigation and as defined in the Drug and Cosmetics Act wherein the competent authority can file an FIR, it allows the drug inspectors to do so. However, in the present scenario, they are not trained to carry out these activities. Therefore this needs to be examined and statutory requirements should be jointly worked out by state and central authorities.”

Ashish Prasad, Partner- Economic Laws Practice, said, “The issue had to reach to the Supreme Court is quite obvious because the power granted specifically under the D&C act was being used by authorities not so empowered. The Supreme Court has now clarified that only the Drug Inspectors (and not the police) as notified by the central government are competent to initiate criminal proceedings, make arrests for offences falling under chapter IV of the Drugs and Cosmetics Act. And the judgment brings in much-needed clarity as proceedings under the D&C Act were initiated by the police officer who (in most cases) lacked the technical qualification/ knowledge required for handling a science-based legal regime, which included handling of samples as per the procedures laid out in a special act. The procedure required to be followed under the D&C was often given a go by – presumably for lack of knowledge, by these officers which resulted in protracted litigations. Therefore, the court has clarified that the judgment will be prospective, thereby granting protection to the complaints /arrest made by an authority other than drug inspector.”

Envisaging the issues likely to come up, Mahendra Bajpai, Lawyer, Supreme Court commented, “This judgment is bound to create problems as the drug inspectors are neither trained nor equipped to discharge duty as a policeman. The policymakers will either have to amend this pre-independence enactment or make rules and regulations to impart requisite training to drug inspectors. Until this happens, this judgment will only add chaos to an otherwise invisible and non-functional authority under the Act.”

An industry observer pointed out that it will not really work in favour of the industry. Since they will be the sole authority, there are high possibilities that they (Drug Inspectors) will arm-twist the matter according to their subject understanding. He also expressed that there is a high possibility of the system getting corrupt and being misused.