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PRESENTED BYChiranjibi Adhikari M. Pharm. 1st yearSUBMITTED TODr. Gururaj S Kulkarni M. Pharm., Ph. D.,Professor and HOD,Department of Pharmaceutics,Mallige College of Pharmacy.#71, SILVEPURA, BANGALORE: 560 090

MAJOR BODIES REGULATING INDIAN PHARMACEUTICAL SECTOR, CDSCOSEMINAR ON

To regulate means to control something so that it functions properly.Drug Regulatory Affair is a function which regulates the pharmaceutical science in order to facilitate trade / business in and outside the country of origin for public interest.Effective drug regulation is required to ensure the safety, efficacy and quality of drugs. The drug regulation mainly consists of:Drug Regulatory BodiesDrug LawsQuality ControlDrug Information Centers etc.

Why RA in Pharmaceuticals??

The Pharmaceutical sector has been ever growing and with globalization, the race to lead to be first is no more restricted by boundaries. Companies success lies in the time taken by the product to reach the market. The companies responsible for the discovery, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. On an average it takes 15-20 years for a new drug development, and it cost around $800-1000 million. Companies cannot afford a single day delay in getting the product to the market.

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US FDA

TGA

HPFBI

CDSCO

Different Regulatory Bodies

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Japan: MHLW (Ministry of Health, Labor, and Welfare )

South Africa : MCC (Medicines Control Council)

UK: MHRA (Medicines and Healthcare products Regulatory Agency)

Russia: CIS (Commonwealth of Independent States)

Brazil: ANVISA (National Health Surveillance Agency)

China : SFDA (State Food and Drug Administration)

ASEAN (Association of South East Asian Nations)Singapore, Malaysia, Thailand, Philippines, Indonesia, Laos, Cambodia, Vietnam , Brunei Darussalam, Myanmar

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Indian Pharmaceutical Evolution

Phase IIGovernment ControlIndian Patent Act 1970Drug prices cappedLocal companies begin to make an impactPhase III Development PhaseProcess developmentProduction infrastructure creationExport initiativesPhase IVGrowth PhaseRapid expansion of domestic marketInternational market developmentResearch orientationPhase VInnovation and ResearchNew IP lawDiscovery Research

19701980199020002010Phase IEarly YearsMarket share domination by foreign companiesRelative absence of organized Indian companies7

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Fastest growing industry in India with CAGR of about 30%India pharma market size $19 billion crore on the basis of sales.India is the worlds 4th largest producer of pharmaceuticals by volume. (accounting for around 8% of global production)Indian company meets 95% of domestic sales.270 large R&D based pharmaceutical companies in India and their share is around 70%.India produces 22% of world generics. Per capita consumption of drugs is very low $93 as compared to $412(Japan), $222(Germany), $191(US).India among top 5 bulk drug producers in world.Ranbaxy is 7th worlds largest generic manufacture.

Current Scenario of Indian Pharmaceutical Industry8

Drug Regulatory Bodies in IndiaDrug 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.The Department of Chemicals and Petrochemicals also oversees policy, planning, development and regulation pertaining to the pharmaceutical sector.There are also 35 state-level Food and Drug Administrations.

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NATIONAL GOVERNMENTMinistry of Chemicals and fertilisers

Ministry of health and family welfare

CDSCONPPADepartment of Chemicals & petrochemicalsDrugs Controller General of India

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Central Drug Standards and Control Organization(CDSCO)

It is the principal national drug authority based in New Delhi, established under the Drugs and Cosmetics Act 1940.CDSCO is headed by the Drugs Controller General of India (DCGI), presently Dr. G.N. Singh.Vision - to protect and promote public health in India.Mission- to safeguard and enhance public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices.

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CENTRAL AUTHORITIES-Approves pre-clinical and clinical trials, Approves licences to manufacture the drugs by acting as Central License Approving Authority(CLAA).The market authorization of new drugs,Supervision of quality of imported drug imports and Guidance on technical matters.

STATE AUTHORITIES-licensing a drug makers research and manufacturing facilities. Monitor quality control.Distribution and sale of drugs.

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Functions of the CDSCO

Laying down standards of drugs, cosmetics, diagnostics and devicesLaying down regulatory measures, amendments to Acts and Rules. To grant marketing authorization of new drugs. To regulate clinical trials in India. To approve licenses to manufacture certain categories of drugs as Central License Approving Authority i.e. for Blood Banks, Medical Devices, r-DNA drugs, Large Volume Parenterals and Vaccines & Sera. To regulate the standards of imported drugs.

Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC). Pharmacovigillance program of India. Coordinating activities of the State Drugs Control Organizations to achieve uniform administration of the Act and providing policy guidance. Guidance on technical mattersMonitoring adverse drug reactions (ADR). Participation in the WHO GMP certification scheme. Conducting training programs for regulatory officials and Government Analysts.

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Drug Controller General of India is an apex body in the pharma industry governing issues such as approval/NOC for clinical trials, bioequivalence studies and marketing permission in India. It is responsible for approval of licenses of specified categories of drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera. It also registers all imported drugs, new drugs, and medical devices.Also responsible for licensing of blood banks, amendments in D&C acts and rules from time to time.

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APPROVAL OF INVESTIGATIONAL NEW DRUG

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CENTRAL LICENSING

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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.In order to streamline the procedure of pricing and to bring transparency, NPPA was constituted with the powers to fix prices and notify the changes therein, if any, of bulk drugs and formulations from time to time. Pricing policy and industry regulation constitutes the key responsibility of the NPPA.

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NPPA is entrusted with the task of recovering amounts overcharged by manufacturers for the controlled drugs from the consumers.Drug prices in India are among the lowest in the world and imports are therefore negligible.Drugs with high sales and a market share of more than 50% are subjected to price regulation. Price control is exempted for the following:New drugs discovered in India.Bulk drugs produced from the basic stages by a new process discovered in India.Drugs manufactured by small-scale industries and sold under their own brand names.

DEFICIENCIES & LIMITATIONS OF DRUG REGULATORY SYSTEMLack of transparency in licensing procedures.Inadequate regulatory expertise and testing facilities to implement uniform standards.Need for greater coordination and transparency in functioning among different ministries concerned with drug regulation.Proliferation of spurious and substandard drugs in the Indian market.Only one- tenth of drug market is price controlled.

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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).18-03-201622

REFERENCES:Sarda Rohit R et al. The Indian pharmaceutical Industry; evolution of regulatory system and present scenario. IRJP 2012; 3(6).Hasumati Rahalkar. Historical overview of pharmaceutical industry and drug regulatory affairs. Kurz Pharmaceut Reg Affairs 2012, S11-002.www. cdsco.nic.inwww.slideshare.netwww.wikipedia.org

THANK YOU FOR YOUR ATTENTION!

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