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REGULATION OF DRUG SECTOR IN INDIA

PRESENTED BY,SHARATH GOWDAIII/I

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CONTENTS

DEFINITION INTRODUCTION DRUG REGULATORY BODIES CDSCO NPPA DRUG LAWS GOOD MANUFACTURING PRACTICES DEFICIENCY AND LIMITATIONS RECENT REGULATORY INITIATIVES

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DEFINITION

Quality control is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the customer.

“To regulate means to control something so that it functions properly.”

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INTRODUCTION Drugs play an important role in the health

of both people and the economy of a country.

Its quality is critical to patient health and poor quality can lead to-

Treatment failure Adverse effects Prolonged illness Distrust in healthcare system Waste of limited financial resources Death

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Hence effective drug regulation is required to ensure the safety, efficacy and quality of drugs.

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The drug regulation mainly consists of:1. Drug Regulatory Bodies2. Drug Laws3. Quality Control4. Drug Information Centers etc.

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Drug Regulatory Bodies

The principal regulatory bodies entrusted with the responsibility of ensuring the approval, production and marketing of quality drugs in India at reasonable prices are:

Central Drug Standards and Control Organization(CDSCO).

National Pharmaceutical Pricing Authority(NPPA).

Drug Controller General of India.

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DRUG POLICY FORMULATION IN INDIA

Drug policies in India are formulated by the Ministry of Chemicals and Fertilizers and the Ministry of Health and Family Welfare.

The former takes the decision on pricing of drugs and the latter looks into quality, manufacture, sales and distribution of drugs.

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Apart from these ministries, The Department of Chemicals and Petrochemicals also oversees policy, planning, development and regulation pertaining to the pharmaceutical sector.

Central Drug Standards and Control Organization(CDSCO)

It runs under the aegis of The Ministry of Health and Family Welfare.

Established under the Drugs and Cosmetics Act 1940.

Objective- prescribes standards and measures to ensure the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country.

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regulates the market authorization of new drugs and clinical trials standards.

supervises drug imports and approves licences to manufacture the drugs by acting as Central License Approving Authority(CLAA).

Regulates the clinical research. Guidance on technical matters.

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CDSCO is headed by the Drugs Controller General of India.

It has a network of 6 zonal offices and 4 sub-zonal offices and 7 port offices.

Port offices monitor import and export of drugs.

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NATIONAL PHARMACEUTICAL PRICING AUTHORITY(NPPA)

NPPA was established, to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs Prices Control Order(DPCO), 1995. 

Pricing policy and industry regulation constitutes the key responsibility of the NPPA.

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NPPA

Drugs with high sales and a market share of more than 50% are subjected to price regulation.

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NATIONAL GOVERNMENT

Ministry of Chemicals and fertilisers

Ministry of health and family welfare

CDSCO NPPA

Department of Chemicals &

petrochemicals

Drugs Controller General of

India

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DRUG LAWS:

The quality control of the drugs marketed in the country is regulated under the following laws-

The Drugs and Cosmetics Act, 1940 Pharmacy Act of 1948 Drugs and Magic remedies Act of 1954 Drugs Prices Control Order 1995

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THE DRUGS AND COSMETICS ACT(1940)

SCHEDULES OF THE ACT Some of the important schedules of the

Drugs and Cosmetic Acts include: Schedule D: dealing with exemption in

drug imports. Schedule M: deals with Good

Manufacturing Practices involving premises and plants.

Schedule Y: specifies guidelines for clinical trials, import and manufacture of new drugs.

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Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

There exists a dual regulatory control on drug policy.

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CENTRAL AUTHORITIES- approval of New Drugs Clinical Trials lays down the standards control over the quality of imported Drugs coordination of the activities of State Drug

Control Organisations.

STATE AUTHORITIES- issue licences for manufacture of approved

drugs. Monitor quality control. Distribution and sale of drugs.

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APPROVAL OF INVESTIGATIONAL NEW DRUG

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CENTRAL LICENSING

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THE DRUGS & MAGIC REMEDIES ACT(1954):

It controls the advertisements regarding drugs,

it prohibits the advertising of remedies alleged to possess magic qualities.

THE PHARMACY ACT(1948): An Act to regulate the profession of

pharmacy.

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GOOD MANUFACTURING PRACTICES(GMP)

GMP constitute an international set of guidelines for the manufacture of drugs and medical devices in order to ensure the production of quality products.

Objectives- to minimize risks with reference to the manufacturing, packaging, testing, labelling, distributing and importing of drugs, cosmetics, medical devices, blood and blood products, food items etc.

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The WHO-GMP certification, which possesses two-year validity, may be granted both by CDSCO and state regulatory authorities after a thorough inspection of the manufacturing premises.

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CLINICAL TRIALS In recent years, India has positioned itself

as one of the major players in the clinical trials arena.

Clinical trials to establish the safety and efficacy of drugs constitute nearly 70% of research and development costs.

Considering the relatively low costs of R&D in India, several MNC pharmaceutical companies are increasingly making India a clinical research and development hub.

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Phase-wise break-up of clinical trials carried out in India

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DEFICIENCIES & LIMITATIONS OF DRUG REGULATORY SYSTEM

Proliferation of spurious and substandard drugs in the Indian market.

Lack of transparency in licensing procedures.

Inadequate regulatory expertise and testing facilities to implement uniform standards.

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Need for greater coordination and transparency in functioning among different ministries concerned with drug regulation.

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Recent regulatory initiatives: Move to establish National Drug

Authority so that quality regulation and price control is performed by the same agency.

Establishment of pharmacovigilance centres at national, zonal and regional levels to monitor adverse drug reactions.

Move to bring nearly 374 bulk drugs under price control.

Monitoring clinical trials by setting up of the Clinical Trials Registry of India (CTRI).

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