Role of all the government pharma regulator bodies –Central Drugs Standards Control Organization (CDSCO), Indian Pharmacopoeia Commission (IPC)

Central Drugs Standards Control Organization (CDSCO),

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India. It operates under the Directorate General of Health Services in the Ministry of Health and Family Welfare. Its headquarters is located at FDA Bhawan, Kotla Road, New Delhi. It also has nine zonal offices, seven sub-zonal offices, eighteen Port offices, seven central laboratories, and six mini-laboratories spread across the country.
Role

The CDSCO plays a crucial role in ensuring the safety, efficacy, and quality of drugs, pharmaceuticals, and medical devices in the country. Under the Drugs and Cosmetics Act, CDSCO is responsible for the approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, and control of the quality of imported Drugs in the country. CDSCO works in coordination with State Drug Regulatory Authorities to ensure the effective implementation of regulations across the country.

The following are the Key roles, functions, and responsibilities of the CDSCO:

• 1. Regulatory Approvals: The CDSCO is the apex regulatory body for pharmaceuticals and medical devices in India. It formulates and implements regulations to ensure the safety, efficacy, and quality of drugs and healthcare products.

• 2. Further CDSCO along with state regulators, is jointly responsible for the grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera.

• 3. Quality Control: The organization is involved in setting and enforcing standards for the quality of drugs and pharmaceuticals. This involves monitoring and regulating manufacturing practices to ensure compliance with Good Manufacturing Practices (GMP).

• 4. Clinical Trials Oversight: CDSCO oversees and regulates clinical trials of new drugs to ensure that they are conducted ethically and adhere to regulatory guidelines.

• 5. Medical Devices Regulation: In addition to pharmaceuticals, CDSCO is involved in the regulation of medical devices. It lays down standards and regulatory requirements for the manufacturing and import of medical devices.

• 6. Pharmacovigilance: The CDSCO is involved in monitoring and assessing the safety of drugs in the market through pharmacovigilance activities. This includes the collection, analysis, and reporting of adverse drug reactions.

• 7. Control of Narcotics and Psychotropic Substances: CDSCO plays a role in controlling the manufacture and distribution of narcotics and psychotropic substances by issuing licenses and regulating their use.

• 8. International Collaboration: The organization collaborates with international regulatory bodies and organizations to stay updated on global standards and best practices. This collaboration is essential for maintaining the quality and safety of pharmaceuticals in the global market.

• 9. Advisory Functions: CDSCO provides expert advice to the government on matters related to drug regulation, quality control, and other pharmaceutical-related issues.

The Indian Pharmacopoeia Commission (IPC)

Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. IPC is created to set standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for the treatment of diseases prevailing in this region. It publishes official documents for improving the Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP). It further promotes the rational use of generic medicines by publishing the National Formulary of India. IP prescribes standards for the identity, purity, and strength of drugs essentially required from the health care perspective of human beings and animals. IPC also provides IP Reference Substances (IPRS) which act as a fingerprint for identification of an article under test and its purity as prescribed in IP.

The Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare, Government of India. It plays an important role in the regulation and standardization of pharmaceuticals in India.

The following are the roles and responsibilities of the Indian Pharmacopoeia Commission:

• 1. Publication of Indian Pharmacopoeia: The IPC publishes the Indian Pharmacopoeia (IP). IP is a comprehensive document containing monographs on drugs and pharmaceutical substances, as well as general chapters on quality control and testing procedures. The Indian Pharmacopoeia is periodically revised to incorporate updates and new standards.

• 2. Setting Standards: The IPC is responsible for establishing and updating standards for drugs and pharmaceuticals in India. These standards are for the identification, purity, and strength of drugs and pharmaceuticals. These are outlined in the Indian Pharmacopoeia (IP). IP serves as an authoritative reference for the quality and safety of drugs.

• 3. Publication of the National Formulary of India: IPC promotes the rational use of generic medicines by publishing the National Formulary of India.

• 4. IP Reference Substances (IPRS): IPC provides IP Reference Substances (IPRS) which act as a fingerprint for the identification of an article under test and its purity as prescribed in IP.

• 5. Quality Assurance: The IPC aims to ensure the quality, safety, and efficacy of pharmaceutical products in the country. It helps to set and maintain standards, promotes the production of high-quality drugs, and ensures that they meet the specified criteria.

• 6. Drug Regulation: The standards set by the IPC are used by regulatory authorities, such as the Central Drugs Standard Control Organization (CDSCO), for the approval and regulation of pharmaceutical products. These standards provide a basis for evaluating the quality of drugs in the market.

• 7. Promoting Research and Development: IPC encourages research and development activities in the field of pharmaceuticals. By establishing standards, it provides a framework for scientists and researchers to work towards improving drug formulations and manufacturing processes.

• 8. International Collaboration: The IPC collaborates with other pharmacopeias and regulatory bodies globally to align standards and practices. This collaboration is important for ensuring the compatibility of Indian pharmaceutical products with international standards, facilitating trade, and promoting global healthcare standards.

• 9. Training and Education: IPC is involved in organizing training programs, workshops, and seminars to enhance the knowledge and skills of professionals in the pharmaceutical industry. This contributes to the overall improvement of quality control and manufacturing practices in the sector.

• 10. Advisory Role: The IPC serves as an advisory body to the government on matters related to the quality of pharmaceuticals. It provides expert opinions and recommendations to assist in the formulation of policies and regulations in the pharmaceutical sector.

• In summary, the Indian Pharmacopoeia Commission plays a pivotal role in maintaining the quality and safety of pharmaceuticals in India. It achieves this through the establishment of standards, collaboration with international bodies, and active involvement in regulatory processes and education initiative

Alok Bains