Ayushi Srivastava*, Veena Gupta
QC Department,
Akums Drugs & Pharmaceuticals Ltd, Haridwar, India

This article undertakes a review and assessment of regulatory framework in the Indian pharmaceutical industry. Understanding the regulatory circumstances in this segment is extremely critical. The Pharmaceutical industry is one of the major industries in India and it contributes a large share in the overall macro level growth of the India. It is one of the most dynamic sectors in the country but its compliance structure is more complex. The pharmaceutical industry has always been a buoyant sector in the eyes of Investors. With increasing returns, lower risks and high growth, investors are more interested in this industry than ever before.


PharmaTutor (Print-ISSN: 2394 - 6679; e-ISSN: 2347 - 7881)

Volume 4, Issue 6

Received On: 25/01/2016; Accepted On: 05/02/2016; Published On: 01/06/2016

How to cite this article: Srivastava A, Gupta V; Regulatory Canvas of Indian Pharmaceutical Industry: Challenges and Future; PharmaTutor; 2016; 4(6); 15-19

Since 2000, the drugs and Pharma sector became the prime temptation for the foreign investors, (FDI) inflows of approximately $12,689 million (April 2000 to September 2014) [1] can prove the credibility of the above sentence. Earlier pharmaceutical industry was known for only or manufacturing generic drugs but presently the Indian Pharma industry evolved and showing its expertise in various activities including research and development (R&D), manufacturing of branded, generic and branded generic drugs, manufacturing APIs, laboratory testing and clinical research. The Indian Pharma industry ranks fourth in terms of volume and 13th in terms of value globally. [2]

Now India has become a prime goal for manufacture of branded, generic and branded generic medicines with strong export strength. It is estimated that around 40 per cent of the generic drugs in the US come from India and with Obamacare being introduced this figure is set to raise further. [3]

Expenditure structure of Indian pharmaceutical industry has also changed now companies are up to 18% of their revenue is spending on R&D [4].

Here are following some regulatory bodies which are working as pillars to hold the regulatory infrastructure of pharmaceutical industry of India:

1. The Central Drug Standards and Control Organization (CDSCO):
CDSCO comes under the umbrella of the Ministry of Health and Family Welfare. The CDSCO prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country? Regulates the market authorization of new drugs and clinical trials standards? Supervises drug imports and approves licenses to manufacture the above mentioned products.

2. The National Pharmaceutical Pricing Authority (NPPA):
The National Pharmaceutical Pricing Authority (NPPA) is responsible for fixing the prices of bulk and formulation of drugs within the National List of Essential Medicines (NLEM). It is instituted in 1997 under the Department of Chemicals and Petrochemicals, which fixes or revises the prices of decontrolled bulk drugs and formulations at judicious intervals? Periodically updates the list under price control through inclusion and exclusion of drugs in accordance with established guidelines? Maintains data on production, exports and imports and market share of pharmaceutical firms? And enforces and monitors the availability of medicines in addition to imparting inputs to Parliament in issues pertaining to drug pricing.

3. ICMR (Indian Council of Medical Research):
Major functions of ICMR are to Formulates, Coordinates and Promotes biomedical research & Ethical Principles.

4. GEAC (Genetic Engineering Approval Committee):
To Manufacture, Use, Import of Hazards Microorganisms/Genetically Engineered Organisms or Cells.

5. Department of Biotechnology:
It promotes transgenic research, molecular biology of human genetic disorders, brain research, and commercialization of diagnostic kits and vaccines for communicable diseases.

6. AERB (Atomic Energy Review Board):
Promotes Radio therapy & Research, Safety review for Gamma Irradiators (Devices).

7. BARC (Bhabha Atomic Research Centre):
Promotes Isotopes application in Medicine & also monitoring usage of radioactive materials

8. DTAB (Drug Technical Advisory Board):
To advise Central & State Govt. on Technical Matters arising out of the Drugs & Cosmetics

9. RCGM (Review Committee on Genetic Manipulation):
No Objection Certificate for Clinical Trial & also r-DNA strains

10. DCC (Drug Consultative Committee):
It is an advisory Committee to DTAB and Central & State Govt. for uniform implementation of various provisions of the Act.

11. DOP (Department of Pharmaceutical):
It has formed in 2008 under the Ministry of Chemicals and Fertilisers. The MoHFW examines pharmaceutical issues within the larger context of public health while the focus of the DoP is on industrial policy.

There are few trade associations in the industry representing different groups of producers, the Organisation of Pharmaceutical Producers of India (OPPI) representing big Indian Pharma with high R&D base, Indian Pharmaceutical Association (IPA) a professional association of pharmacists in India. Indian pharmaceutical Alliance (IPA); Confederation of Indian Pharma Industry (CIPA) – the apex body of small scale manufacturers of drugs and Pharma in India; Bulk Drug Manufacturers Association (BDMA); and Indian Drug Manufacturing Association (IDMA).

In India, the drug manufacturers and exporters not only have to meet the standards set by the Drug Controller General of India (DCGI) but also standards benchmarked by the Drug Regulators of the countries to which the product is being exported. The regime of compliance is becoming stronger as regulators look for greater compliance from the industry given the mounting consumer pressures, and increasing healthcare standards. In addition, regulatory authorities are increasing the scrutiny related to patient safety and compliance.

Drugs and Cosmetics Act, 1940 is the law which regulates the import, manufacture, distribution and sale of drugs and cosmetics in this country. The Drugs and Cosmetics Act, 1940 and Drug and Cosmetic Rules, 1945 have elaborate provisions to check the production of spurious and substandard drugs in the country. [5]

12. CDA: (Central Drug Authority)
The CDA was established as an advisory body in terms of the Prevention of and Treatment for Substance Abuse Act (Act No. 70 of 2008) and is mandated to assist in the fight against substance abuse in the country. The primary function of the CDA is to monitor the implementation of the NDMP. The CDA ensures coordination, facilitates integration of the work of different departments and reports to parliament through the minister for social development.[6]



Subscribe to Pharmatutor Alerts by Email