12. ROLE OF ALL THE GOVERNMENT PHARMA REGULATORY BODIES

GOVERNMENT PHARMA REGULATORY BODIES

Regulatory agencies are developing in various nations throughout the world as the pharmaceutical industry advances toward greater competition. Organisations and regulatory bodies are essential to a nation’s ability to comply with legal obligations pertaining to the drug development process. India is now one of the largest markets for pharmaceutical products. India’s healthcare industry is now a separate industry due to the development of new technology, the growth of rural markets, and the expansion of private healthcare facilities.

ROLE OF GOVERNMENT PHARMA REGULATORY BODIES

1. Maintaining and safeguarding reserved rights or reserved practices in the interest of the general public.
2. Governing the regulating body’s registrants in accordance with the bylaws and regulations.
3. Specifying the prerequisites or conditions for registering with the regulatory agency.
4. Creating, overseeing, and upholding rules of conduct to improve practice quality and prevent:
   • Professional misconduct
   • Conduct unbecoming a registrant
   • Incompetent performance of duties
5. Establishing transparent, objective, unbiased, and fair procedures for registration, investigations, and discipline.
6. Managing the affairs of the regulatory body and carrying out its duties under the PGA or other enactments.
7. Establishing and maintaining a continuing competency program to encourage high practice standards.
8. Establishing, monitoring, and enforcing standards of professional ethics among registrants.

LIST OF GOVERNMENT PHARMA REGULATORY BODIES

• Central Drug Standard Control Organisation (CDSCO)
• Ministry of Health & Family Welfare (MHFW)
• Indian Council of Medical Research (ICMR)
• Indian Pharmaceutical Association (IPA)
• Drug Technical Advisory Board (DTAB)
• Central Drug Testing Laboratory (CDTL)
• Indian Pharmacopoeia Commission (IPC)
• National Pharmaceutical Pricing Authority (NPPA)

CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)

The CDSCO is a national regulatory authority of India that has 379 staff members and works under the Directorate General of Health Services of the Ministry of Health & Family Welfare. The Drugs Controller General of India (DCG(I)) heads the CDSCO. A steep rise in recruitment has occurred from 111 positions in April 2008 to 474 positions currently.

Structure of CDSCO

• Zonal Offices: 9
• Sub-zonal Offices: 7
• Port Offices: 18
• Central Laboratories: 7
• Mini Labs: 6

Functions of CDSCO

1. Makes policies and procedures for uniform implementation of the Drugs & Cosmetics Act, 1940 and Rules, 1945.
2. Assists in setting and implementation of standards for drugs, cosmetics, and medical devices.
3. Coordinates and interacts with international organisations (WHO, U.S. FDA, EMA, PMDA Japan, EDQM, SAARC, SEARO, BRICS).
4. Controls import of medicines, approval of new medicines and clinical trials, conducts DCC and DTAB meetings, functions as Central Licence Approving Authority (CLAA).
5. Performs inspections along with Zonal Offices and coordinates with state Drugs Controllers.
6. Exercises quality control of imported medicines through port offices.
7. Maintains drugs testing laboratories for sample testing.

INDIAN PHARMACOPOEIA COMMISSION (IPC)

The Indian Pharmacopoeia Commission (IPC) is an autonomous institution under the Ministry of Health and Family Welfare of the Indian government. IPC was established to create drug standards in the country. Its primary function is to keep track of drug standards used to treat ailments prevalent in the region.

Objectives of IPC

1. To promote highest standards of drugs for human and animal consumption within practical limits of manufacturing and analysing technologies.
2. To improve public and animal health in India by establishing authoritative and officially recognised quality standards for drugs, including APIs, excipients, and dosage forms.

Structure of IPC

• Began operations as an autonomous institution on 1st January 2009.
• Organised into three levels: General Body, Governing Body, and Scientific Body.
• General Body: 25 members
• Governing Body: 13 members
• Scientific Body: 23 members
• Expert Committees: 13 members
• The Chief Scientific and Executive Officer is the Secretary-cum-Scientific Director.

Functions of IPC

1. Publishing a new edition and addendums of the Indian Pharmacopoeia (IP).
2. Publishing the National Formulary of India (NFI).
3. Providing certification and dissemination of IP Reference Substances (IPRS).
4. Functioning as National Coordination Centre (NCC) for operating Indian Pharmacovigilance Program (PvPI).
5. Forming working relationships with other national and international institutions having similar positions.
6. Planning educational programmes, skill development initiatives, and research activities.

SUMMARY: KEY REGULATORY BODIES AT A GLANCE

Dr. Saint Paul

Dr. Saint Paul is a pharmacy educator, Pharm.D graduate, and academic content creator from Jawaharlal Nehru Technological University Kakinada (JNTUK), where he completed his Doctor of Pharmacy (Pharm.D) degree between 2015 and 2021.

He has more than 7 years of experience creating pharmacy educational content, writing study materials, and reviewing academic articles for pharmacy students. He has also contributed guest articles to pharmacy education platforms, including PharmD Guru.

At D.PharmGuru, his work focuses on simplifying complex Diploma in Pharmacy (D.Pharmacy) subjects into easy-to-understand notes, practical explanations, and exam-oriented educational resources for students across India.

His areas of focus include Human Anatomy and Physiology, Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Hospital and Clinical Pharmacy, and other core D.Pharmacy subjects.