PHARMA INDUSTRY AND REGULATORY INSTITUTIONS – Continued

PHARMACUITICAL INDUSTRY IN INDIA

Pharmaceuticals Export Promotion Council of India(PEPCI) Report says

#Global Pharma market size in the calendar year 2016 is estimated at $1100 billion as per IMS with a very marginal growth rate of 3%.

#In terms of the global market, India currently holds a modest 1–2% share, but it has been growing at approximately 10% per year

#India’s total exports of Pharmaceuticals (APIs, Generics and Alternative system of medicine) during 2016-17 was $16.84 billion with a negative growth of 0.43%.

#Global generic market is estimated to be of size $ 294 billion. India, a predominant player in Global Generic market has clocked $ 12.7 billion of Exports out of a total $ 294 generic market with a growth of 0.42 % during the year2016-17

CHALLENGES OF HEALTH SECTOR AND PHARMACUITICAL INDUSTRY

1.Accessibility : huge populationof India and their dispersion in difficult and varied geographical regions…

2.Affordability : still lot of people unrmployed or work with meagre salary

3.Quality : better pharma products an essentail requirement..

4.Others : patent issues, corruption and malpractices in govt sector, Environmental concerns….

 

Overall we can say that pharma industry has a major impact in indian society as its core effects are on

#Health , as a fundamental Right and

#Public Order : in terms of economy, society, environment and ethics……

Therefore this pharma sector become a major cector for regulation……

 

NATIONAL PHARMACEUITICAL PRICING AUTHORITY (NPPA)

#It is an independent body of experts under the Ministry of Chemicals amd Fertilizers established in the year 1997

#it is not a statutory body

Major functions of NPPA are 

  1. The functions of NPPA include fixation and revision of prices of sheduled drugs (those medicines included in schedule 1 of DPCO which are subject to price control) and formulations 
  2. To implement and enforce the provisions of the Drugs Price Control Order (DPCO), 1995/2013  in accordance with the powers delegated to it
  3. To undertake and/or sponsor relevant studies in respect of pricing of drugs/formulations.
  4. To monitor the availability of drugs, identify shortages, if any, and to take remedial steps.
  5. To collect/maintain data on production, exports and imports, market share of individual companies, profitability of companies etc. for bulk drugs and formulations.
  6. To deal with all legal matters arising out of the decisions of the Authority.
  7. To render advice to the Central Government on changes/revisions in the drug policy.
  8. To render assistance to the Central Government in the parliamentary matters relating to the drug pricing.
  9. The organisation is entrusted with the task of recovering amounts overcharged by manufacturers for the the controlled drugs from the consumers

 

 

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