Pharma Regulatory Bodies

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The given information is compiled from various offline / online sources, towards the sole

purpose of knowledge sharing.

Module 3

Pharma regulatory bodies

In India:

The Drugs and Cosmetics Act, 1940: The import, manufacture, distribution and sale of drugs in India are regulated by this act.

Schedule M of the Drugs and Cosmetics Act specifies the requirements for factory premises and materials, plant and equipment and basic installations for certain categories of drugs.

Schedule T of the Drugs and Cosmetics Act prescribes GMP specifications for the manufacture of Ayurvedic, Siddha and Unani medicines.

Schedule Y of the Drugs and Cosmetics Act governs the clinical trials.

The Pharmacy Act, 1948: This legislation regulates the Pharmacy Profession in India.

Central Government constitutes a Central Pharmacy Council of India and the State Governments constitute State Pharmacy Councils.

The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954: This Act controls the advertisements regarding drugs and prohibits the advertising of remedies alleged to possess magic qualities.

The Narcotic Drugs and Psychotropic Substances Act, 1985: This act concerns with the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances.

The Medicinal and Toilet Preparations (Excise Duties) Act, 1956: Provides the levy and collection of duties of excise on medicinal and toilet preparations.

The Drugs Price Control Order (DPCO), 1995: Issued under the Essential Commodities Act, 1955 to regulate the prices of drugs. Provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by Government and penalties for contravention of provisions among other things.

National Pharmaceutical Pricing Authority (NPPA) is empowered to implement provisions of DPCO.

Good Clinical Practice (GCP) Guidelines: Based on Declaration of Helsinki, World Health Organization (WHO) guidelines and International Conference on Harmonization (ICH) requirements for good clinical practice the Ministry of Health, along with Drugs Controller

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General of India (DCGI) and Indian Council for Medical Research (ICMR) has come out with draft guidelines for research in human subjects.

The following laws also govern the manufacture, distribution and sale of pharmaceutical products in India:

The Industries (Development and Regulation) Act, 1951

The Trade and Merchandise Marks Act, 1958

The Indian Patent and Design Act, 1970

Factories Act

Regulatory Bodies:

The Ministry of Health & Family Welfare (MoHFW) and the Ministry of Chemicals and Fertilizers (MoC&F) of the Government of India regulate the pharmaceutical sector in the country.

Ministry of Health & Family Welfare (MoHFW):

Department of Health: The following are the main agencies of the department which deal with key issues including drug approvals:

Central Drugs Standard Control Organisation (CDSCO): Works at both Central and State levels and responsible for ensuring safety, efficacy and quality of drugs supplied to the public. Functions with the Drugs Controller General of India (DCGI) as the executive head.

Drugs Controller General of India (DCGI): The DCGI governs issues such as product approval and standards, clinical trials, introduction of new drugs, import licenses for new drugs and enforcing new drug legislation.

Department of Health administers the following major acts:

The Drugs & Cosmetics Act, 1940

The Prevention of Food Adulteration Act

The IMA Act

The Tobacco Control Act

Ministry of Chemicals and Fertilisers (MoC&F): Constitutes bodies such as the Department of Chemicals & Petrochemicals and the National Pharmaceutical Pricing Authority (NPPA). These departments are responsible for policy making, planning, development and regulations relating to Chemicals, Petrochemicals and Pharmaceuticals.

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Department of Chemicals & Petro-Chemicals: Formulates and implements policies and programmes to achieve growth and development of pharmaceuticals in the country. The Department has undertaken several initiatives to attract investment into the sector, the major being the Pharmaceutical Policy with the objective of strengthening production, export & R&D.

The first comprehensive pharmaceutical policy formulated in 1978 has been revised through new policy guidelines issued in 1986, 1994 and recently in 2002.

Pharmaceutical Policy 2002 – The main objectives of the policy are:

To ensure availability of quality essential pharmaceuticals at reasonable prices for mass consumption.

To strengthen the indigenous capability for cost effective quality production and export of pharmaceuticals by reducing trade barriers in the pharmaceutical sector.

To implement quality control systems for pharmaceutical production and distribution in the domestic industry.

To encourage pharmaceutical R&D compatible with the country’s needs.

To encourage new investment in the pharmaceutical industry and the introduction of new technologies and new drugs.

Draft Pharmaceutical Policy 2006 - The Department of Chemicals has released the draft of the New Pharmaceutical Policy 2006 which is waiting for approval by the Indian Government.

The draft National Pharmaceutical Policy, 2006 aims at strengthening the Drug Regulatory System and Patent offices in the country. Focuses on research and drug development with clinical trials. Aims at providing a better access to anti-cancer and anti-HIV/AIDS drugs to the patients. Seeks to rationalize the excise duty on pharmaceuticals and to streamline the system of bulk

procurement of drugs by the Government besides promoting the generic medicines.

National Pharmaceutical Pricing Authority (NPPA): Entrusted with the fixation / revision of prices of bulk drugs and formulations, enforcement of provisions of the Drugs (Prices Control) Order and monitoring the prices of controlled and decontrolled drugs in the country.

Drugs Price Control Order (DPCO), 1995: Issued by the Government of India under the Essential Commodities Act, 1955 to regulate the prices of drugs. DPCO controls the domestic prices of major bulk drugs and their formulations with an aim to provide patients with medicines at affordable prices. DPCO ascertains, as per Drug Policy guidelines, the bulk drugs (and their formulations) to be kept under price control.

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At the State level, the State Food and Drug Administration’s (FDAs) monitor the drug manufacture, sale, and testing by companies in their jurisdiction. There are also two main statutory bodies formed by Parliament:

the Drugs Technical Advisory Board, advises the Central and State Governments on special technical matters involving drug regulation, and

the Drugs Consultative Committee, ensures that drug control measures are enforced uniformly in all states.

The domestic pharmaceutical industry is represented by the following three main pharmaceutical associations:

Organization of Pharmaceutical Producers of India (OPPI): Premier association of research based international and large pharmaceutical companies in India and a scientific and professional body.

Indian Drug Manufacturers’ Association (IDMA): Represents domestic manufacturers and plays a vital role in the growth and development of the pharmaceutical industry, by taking up with the Government major issues such as Price Control, Patents and Trade Marks Laws, Quality & GMP, R&D, Exports and so on.

Indian Pharmaceutical Association (IPA): This is the premier professional association of pharmacists in India.

(Adapted from: http://www.indialawoffices.com/pdf/pharmaceuticalmarket.pdf)

http://www.indialawoffices.com/pdf/pharmaceuticalmarket.pdf

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Prevailing Mechanisms for the Regulatory

Control of Pharmaceutical Sector

Major Pharma Policies Drug Policy 1986

Pharmceutical Policy 2002

National Pharmaceutical Policy 2006

Price

Control

IPR

Protection

Quality

Control

On prices On Margins

Bulk Drugs Formulations

GMP

Issues

Essential

Commodities Act

1955

DPCO 1995

Governing

Policies

Amended

Patent

Laws

Drus &

Cosmetics

Act 1940

Schedule M

Patent Act

1970

Product

Patent 2005

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International: WHO (Medicines)

WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines.

WHO sites WHO guidelines on all areas relevant to health of people all over. ICH International Conference on Harmonization of Technical

Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines defining quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States

OECD Organization for Economic Collaboration and Development including 30 member countries covers economic and social issues in areas of health care.

EMEA European Medicines Agency (EMEA), a decentralized body of the European Union headquartered in London, prescribes guidelines for inspections and general reporting and all aspects of human & veterinary medicines in the European Union.

US FDA Regulations, guidelines, notifications, news and communications from US Food and Drug Administration.

TGA Specifications regulating medicines, medical devices, blood, tissues & chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body.

South Africa The department of Health, South Africa. WTO News, resources, documents and publications of the World Trade

Organization (WTO), the global international organization dealing with the rules of trade between nations.

Codex Alimentarius

Collection of international food standards and guidelines for processed, semi–processed and raw foods, adopted by the Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme.

MHRA News, warnings, information and publications of Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring efficacy and safety of medicines and medical devices in the UK.

Health Canada Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada.

Thai FDA Thai Food and Drug Administration laws and regulations with respect to drugs, food, cosmetics and narcotics.

HSA, Singapore Health Sciences Authority (HSA), the regulatory body of Singapore. DOH, Philippines

The Department of Health, Philippines.

Medsafe, New Zealand

Medsafe, New Zealand Medicines and Medical Devices Safety Authority.

http://www.tga.gov.au/

http://www.wto.org/

http://www.doh.gov.ph/

http://www.doh.gov.ph/

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NPCB, Malaysia Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia.

DGMP, Belgium Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium.

BfArM, Germany

Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany

SwissMedic Swiss regulatory agency for therapeutic products. MPA, Sweden Regulatory and surveillance guidelines issued by Medical Products

Agency, Sweden. NAFDAC, Nigeria

News, regulations and guidelines issued by The National agency for Food Administration and Control (NAFDAC), Nigeria.

http://www.swissmedic.ch/?lang=2

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Pharma Regulatory Bodies

Documents

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