The regulation of drugs and cosmetics plays a vital role in ensuring public health and safety. In India, the Drugs and Cosmetics Act 1940 has been the cornerstone for regulating the manufacture, sale and distribution of drugs and cosmetics. However, due to the growth and increasing complexities of the pharmaceutical industry, the legal framework surrounding these regulations needed to be updated for efficient enforcement and combating offences. This resulted in the formulation of the Drugs and Cosmetics (Completion of Offences) Rules, 2025. These rules are intended to provide a more manageable approach to dealing with offences relating to drug licensing and other related activities, and to balance law enforcement with the opportunity for resolution without protracted litigation.

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Understanding the Drugs and Cosmetics (Compounding of Offences) Rules, 2025

The Drugs and Cosmetics (Combination of Offences) Rules, 2025 are framed to regulate how offenses under the Drugs and Cosmetics Act, 1940 can be combined. These rules give people accused of certain offences to resolve their cases without the lengthy trial process. Compounding offenses is essentially an administrative procedure where a combination of lawbreakers can settle the issue by paying money, often leading to immunity from prosecution. The regulations define the roles of the key authorities involved in the process, including the compounding authority and the reporting authority.

It also specifies the conditions under which the compounding process can be initiated, who can apply for compounding, and the required documents. These provisions make it clear that compounding is available after the commencement of litigation, not just before it is instituted. This is an important avenue for resolving disputes arising from breaches of drug licenses and related regulations. The Combination of Offenses Rule provides an alternative approach to traditional legal proceedings, with the aim of saving time and resources for both the government and companies involved in the pharmaceutical sector. This system encourages compliance by offering a more practical solution for violations of the Medicines and Cosmetics Act.

What Are Compounding of Offences?

Compounding of offenses is a legal process that allows individuals or entities accused of a offence to settle without a full trial. Under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, the accused can apply to the Compounding Authority, offering a monetary penalty to resolve the issue. The authority reviews the case, consults with relevant bodies and may grant exemption from prosecution if conditions are met. This process is discretionary and not automatic. For those in the pharmaceutical industry, it provides an alternative to criminal proceedings, with the aim of expediting resolution and minimizing business disruption.

Also Read: What is Form 20 and 21 Drug License?

Key Provisions of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025

The Drugs and Cosmetics (Combination of Offences) Rules, 2025 contain several key provisions that govern the way offenses are combined. Here are the important provisions:

1. Short Title and Commencement: The regulations are officially called the Drugs and Cosmetics (Combination of Offences) Regulations, 2025. These rules became effective as soon as they were published in the Official Gazette on April 24, 2025. Hopefully, their implementation will provide an easier and quicker way to handle offences related to the manufacture, sale and distribution of drugs and cosmetics.
2. Definitions: To understand the rules clearly, it is essential to know the specific terms used in them:

• "Act" means the Drugs and Cosmetics Act, 1940 (23 of 1940),
• "applicant" means any company or any other person(s) involved in manufacturing, import, sale, distribution or other activity covered under the provisions of the Drugs and Cosmetics Act and rules thereunder,
• "compounding authority" means the authority appointed under rule 3 of these rules by the Central Government or State Government, as the case may be,
• "Form" means the Form appended to these rules,
• "reporting authority" means the Licensing Authority or the Central Licensing Authority or the Central License Approving Authority appointed by the Central Government or the Licensing Authority appointed by State Government, as the case may be, under the Act and rules made thereunder, having jurisdiction over the place where an offence under the Act has been or alleged to have been committed,
• "section" means a section of the Act, and
• Words and expressions used in these rules and not defined but defined in the Act shall have the respective meanings assigned to them in the Act.

3. Appointment of Compounding Authority: Under the new rules, the responsibility of appointing compounding authorities lies with the Central Government and the State Government. The person must be an officer of at least the rank of Reporting Authority. The main role of the Compounding Authority is to examine applications for compounding offenses and determine whether to grant immunity from prosecution in lieu of penalty. The Central and State Governments will appoint these officers through notification in the Official Gazette to ensure transparency in the process.
4. Form and Mode of Application: To start the combination process, the applicant must submit an application to the combination authority. This application may be submitted before or after trial. The applicant must provide all necessary details and documentation related to the crime. The application must be submitted on a prescribed form and must be made in person by the company or individual involved in the infringement.
5. Procedure for Compounding: The steps involved are:

• Receipt of Application and Request for Report: Upon receipt of an application under Rule 4, the Compounding Authority shall request a report from the Reporting Authority. Details about the offense will be included depending on the application and other relevant factors.
• Time Limit for Submission of Report: The reporting authority is required to submit the report within one month from the date of receipt of the communication from the compounding authority. The Compounding Authority may extend this period if necessary.
• Review and Decision by the Compounding Authority: Once the Compounding Authority has reviewed the application and the Reporting Authority’s report, it will decide whether to approve or reject the application. If approved, the compounding authority will specify the compounding amount and grant immunity from prosecution. If refused, the applicant must be given an opportunity to be heard and the reasons for the refusal must be given.
• Issuance of Order: After making a decision, the compounding authority shall issue an order to the applicant, providing a copy of the decision in relation to the compounding application.
• Payment of Compounding Amount: The applicant shall pay the specified compounding amount within thirty days of receipt of the order. Proof of payment should be provided to the compounding authority. Once paid, the money cannot be refunded, unless the court rejects the immunity.
• No Automatic Right to Compounding: Applicants do not have an automatic right to compound their felony. The decision rests entirely with the compounding authority.

6. Power to Grant Immunity from Prosecution: One of the most important features of the new rules is the provision of immunity from prosecution. If the Compounding Authority is satisfied that the applicant has fully cooperated with the proceedings and has truthfully disclosed all relevant facts, they may grant immunity from prosecution for the offence. However, immunity may be subject to certain conditions that must be met. This provision provides a significant incentive for companies and individuals to be transparent and cooperative with authorities, as it allows them to avoid the lengthy and expensive process of prosecution.

Also Read: What is the Process of Drug License Renewal?

Advantages of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025

The Drug and Cosmetics (Combination of Offences) Rules, 2025 provides several benefits to businesses and individuals involved in the pharmaceutical industry, especially for drug license holders. These benefits are critical in maintaining smooth operations in the field and efficiently addressing minor infractions:

• Faster Resolution: The compounding process provides faster resolution than the traditional court system. This allows pharmaceutical licensees and other stakeholders in the pharmaceutical industry to avoid lengthy legal battles and quickly return to regular business operations.
• Cost-effective: Litigation can be expensive and time-consuming, whereas compounding offers an affordable and efficient solution. The compounding amount paid is often far less than the cost associated with a full trial.
• Incentives for Compliance: The availability of the compounding option encourages stakeholders to comply with the rules, knowing that minor violations can be resolved quickly. This contributes to a healthy regulatory environment.
• Exemption from Prosecution: If the compounding authority is satisfied with the cooperation of the applicant, it may grant immunity from prosecution. This means that applicants avoid the long-term consequences of a criminal conviction, which can be particularly important for businesses in the pharmaceutical sector.
• Reduce the Legal Burden on the Courts: Combining offenses reduces the number of cases the courts handle, reducing the burden on the judicial system and allowing the courts to focus on more serious cases.
• Transparency and Fairness: The rules ensure that the compounding process is transparent and fair, with clear guidelines on how to apply and how to make decisions. This reduces ambiguity and ensures equal treatment of applicants.

Conclusion

The Drugs and Cosmetics (Combination of Offences) Rules, 2025 represent a significant development in the regulatory framework of the pharmaceutical industry in India. By providing an alternative method of resolving legal violations, these regulations offer numerous benefits to drug license holders and other stakeholders involved in the manufacture, sale, and distribution of drug and cosmetics. Through this process, businesses can resolve issues more efficiently and continue their operations without the financial strain of extensive delays or full-blown litigation. Ultimately, these regulations serve to streamline enforcement of the Drugs and Cosmetics Act, 1940, ensuring that the law is followed while also providing an accessible avenue for those who have committed minor violations. They strike a balance between strict enforcement and providing a way for businesses to maintain compliance, providing a win-win situation for both regulators and the industry.