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 Central Drug Authority




CDA (Central Drug Authority) - On the Way..!!
A major Breakthrough

 

The upcoming changes in regulatory authority promises a lot to global pharmaceutical companies. Current structure of Regulation not only restricts global firms entering the market but also curb the opportunities for India in Global market. Before proceeding further with the impact and benefits of Central Drug Authority, CDA lets discuss the scenario and status of Drug Regulatory and Pharmaceutical Industry in India and globally.

 

History of Pharmaceutical Industry

 

Delving bit deep to the phase when we got independence the figures were not very impressive. But over the decades the trend in figure has witnessed huge growth in the pharmaceutical Industry. The number of units in Pharmaceutical Industry at the dawn of independence was 100 in 1947. Over two decades it leaped a major high of 2000 units in 1970.The figures further shooted as high as 6000 in number in early 90’s. Currently, if not equivalent to the share that Pharmaceutical industry hold but still India occupy a prominent place with 10,000 units as in 2006.The business in terms of financials stands as follows-

 

Volume of Business :

 

Year

Domestic
(in crores)

Exports
(in crores)

1947

15

Nil

1970

8000

2100

1990

12000

6000

2000

22000

12000

2006

36000

22000

 

Status of Drug Regulatory in India


DRA not being an autonomous body vary immensely in their rules and law making in state and Center. The overall objective to ensure that medicinal products quality, Safety and efficacy remains the same but implementing the policy and measures taken tends to differ a lot in the states.

Whereas the manufacturing / sale and quality monitoring of drugs in the country is looked after by state govt respectively, on the other hand the making of legislation, laying down standards, monitoring imports and exports and Clearance of New drugs comes under the scrutiny of Central government.

Besides this there stands some responsibilities that are performed by both State and Center in collaboration jointly. The duties to be performed jointly are mainly approval of license for the manufacture of the following drugs:

 

  • Vaccine & Sera
  • Blood bank & Blood Products
  • r- DNA
  • Large Volume Parenternals
  • Medical Devices.
  • WHO-GMP approvals

 

The amalgamated responsibilities held differently have left the global companies between major haves and haves not. Juxtaposition of Central and state government distinct statutory functions under the act in India , other countries such as USA, Canada,  China, South Africa, Malaysia, Australia, Thailand holds Centralized Drug Regulatory Authority.’

 

CDA formation- Breaking the major hiccup


Dispersed role and responsibility between state and central drug authorities is a major hiccup for global companies to try their hand in India for their business inspite of India’s huge potential in Pharmaceutical industry. Global companies often get baffled as different states in India hold different procedures when it comes to drug regulations. If a certain work takes 15 days in Bombay than the same work may take around 6 months in Jammu and vice versa.

 

With upcoming law on centralizing the drug Authority in India on the recommendation of health committee under the leadership of Hon’ble Dr. Anbumani Ramadoss (Minister of Health and Family Welfare), India will see yet another scintillating face of scope of Pharmaceutical and Healthcare Industry. The idea behind the CDA authority in India is making it as an autonomous body with all the comprehensive powers as per the Drug and Cosmetics (amendment) Bill, 2007.

 

The Central Drug Authority will have a chairman with not more than five members but at least 3 members, to be appointed by Central govt. with the defined criteria for the qualification and procedure of appointment. The CDA office will be maintained at Delhi and all the existing power of CDSCO to be shifted to CDA itself. DCGI(Drug Controller General India) will then work under Chairman with additional DC(I) appointed separately both in AYUSH and Drugs.

 

  Opening opportunities with CDA formation


With the proposed Structure of Drug Regulatory Authority, a plethora of Global opportunities will prop up. These opportunities will cover, contractual manufacture (agreement for global manufacture of pharmaceutical products in compliance to the international standards), contractual research and development including formulation development, clinical research, collaborative clinical trials and customized synthesis, services like analytical method development and validation, clinical data management, ancillary equipment and material production, and manufacture of packaging material. India is a hub for contractual manufacturing process of pharmaceutical products due to its cheapest manufacturing cost across the globe.


Through the centralized licensing, Vaccine manufacturing units in India will gain the most. Only 15 countries around the globe producing vaccines hold Licensing of Vaccines on Global Standards. India will get the cutting edge over others once Central Drug Authority, CDA get formulated as India holds 14 units who manufactures vaccines. While figure for other countries producing vaccines merely reaches to a high of maximum 5 units.


Formation of CDA is expected to support the Indian regulatory system in the present scenario of competition with Asian and East-European countries. The foundation of CDA is laid with the view to introduce new technologies and new therapies along with added benefits of global participation and increasing business opportunities, capacity building, opening employment opportunities, production of cost effective drugs, and economic acceleration through foreign exchange.

 

Summing up

 

In the market on terms of laissez faire structure in pharmaceutical industry it gets bit ossifying to grasp all the issues related to the Regulations and implement them in the right and best ways possible. The area seems beyond the comprehension of  everyone Here, it’s a government call to employ some well educated person to perform the role and give the formation of Central Drug Authority its true meaning. Government can look forward to current Health Minister, Dr. Anbumani Ramadoss or some strong bureaucrats for the Chairmanship of CDA.

 

Central Drug Authority will raise the expectations of global pharmaceutical companies to join hands in India for setting up their units or tie-ups with contract Research organizations (CRO).
 
The fact is that the pharmaceutical market in India has a huge potential when compared to other emerging markets in Asia (China, Thailand, Malaysia etc) and East European countries. To cite an example, India possess 10,000 manufacturing units of pharmaceutical and Active Pharmaceutical Ingredients (API). Following these soaring trends of manufacturing units in India, even premium organization are looking at India as their global production and R&D base and outsourcing hub.

Despite the optimism there are few speed breakers. Of which one of the major was proceeding of centralization of drug Authority at very slow pace. This may partially explain the aggression among the global pharma company to expand the market in other less potential countries. At the same time, there are others who see the value in making India one of their global hubs.

 

The implementation of current amendment on the lines of recommendations by Hathi committee, Mashelkar Committee, National Drug Policy (1986-1994-2000) tends the curb the major gap and will give India its due share in Global Pharmaceutical Industry.



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