The Indian pharmaceutical Industry_An essay I. Aayishamma

INTRODUCTION

       The Indian Pharmaceutical Industry, sized at USD 34 billion in 2013 -14, has remained on a strong growth trajectory, over the Past few years. The Industry size is expected to increase to USD 48 billion by 2017 -18 at a CAGR of 14%.Indian Pharmaceutical Industry is ranked 3^rd globally in terms of volume and in terms of value, supplying 10 % of global production .

  

THE KEY SEGMENTS

A.  API Manufactures/Trades( Bulk Drug)

B.   Formulation Manufactures

C.   Contract Research and Manufacture Services Companies

D.  Biotechnology Companies                                                            

 A. Manufacture/ trades (bulk drug)

    Bulk drug export, constituting 80-90% of total bulk          Production, accounted for about 33% of total sales in the pharmaceutical industry in 2013-14. The share of bulk drugs in higher in Indian as compared with developed countries, where bulk drugs are primarily manufactured for domestic consumption.  

B. FORMULATION MANUFACTURES   

   1. Formulation (domestic)    

            In 2013-2014, the domestic formulations market recorded the lowest growth rate in the last 5 years on account of the implementation of Drug Price Control Order (DPCO). The order, announced in May 2013, led to sharp price revisions across several drugs that have been brought under price control. Around 348 molecules that cover close to 30% of the   total domestic market have been brought within the ambit of this order.

Exports

                                    

        Formulation exports grew at 17% CAGR to an estimated USD 11.1billion in 2013-14 from USD 5.2billion in 2009-10. Growth was enabled by a 22% growth (CAGR) in exports to regulated markets. Exports to semi regulated markets, which have grown at 13% over the same period, also supported growth in overall exports. Exports to these 30 countries grew by nearly 20% and accounted for up to 79% (USD 3.5 billion ) of  the total Indian exports to these two  continents in 2013 -14.  

C. Crams 

         Contact Research and Manufacturing Service is one of the fastest growing segments in the pharmaceutical and biotechnology industry. It pertains to outsourcing research service/ manufacturing products to low – cost providers with world class standards, International regulatory services/ manufacturing products to low-cost providers with world class standards, in line with international regulatory norms such as USFDA, Australian-TGA, UKMHRA, and EMEA.

D.BIOTECHNOLOGY COMPANIES

            Biotechnology refers to the application of scientific techniques using living organisms or their parts to make or modify plants, animals, micro organisms or environment to enhance their performance and values. In the recent years biotechnology has emerged as a major focal point for the developed as well as the developing nations. It has a greater vision to sectors such as human health, agriculture and environmental science for the future.  

                   There are two segments Bio-pharmaceuticals, Bio-services.

Evolution

  Pre- patent regime (before 2005)

       Process Patents helped the Indian pharmaceutical sector flourish, amid a fast growing generics industry. During this regime, multinational companies (MNCs) were reluctant to directly introduce new products in India. 

        Indian Patent Act, 1970

        Drug Price Control Order (DPCO), 1970

        Decline in Share of MNCs

        Growth of Small-Scale Units

POST INDEPENDENT ERA

    This post Independent era related to Pharmacy education.

1949 - D.PHARM Post started institute education

1949 – PCI was established.

1953 – First ER (EDUCATINAL REGULATION).

1955 – First edition of IP-INDIAN PHARMACOPOEIA.

1960 – AICTE Was framed M.PHARMACY

1966 – Second edition of IP

1978 - GATE Examination for M.PHARMACY with scholarship.

1985 – Third edition of IP

1991 – NIPER Was started in MOHARI.

1996 – Fourth edition of IP

2007 – Fifth edition of IP

2008 – PHARM.D Course was introduced.

PRE INDIPENDENT ERA

        It came into India along with British traders. There by pharmacy education in India was started.

         1824- London Pharmacopoeia.

         1840- General medical college or Government medical college or Goa medical college was started in PANJIM.

        1841- Bengal Pharmacopoeia volume 1 was published in KOLKATA.

         1874- Two years course for chemist and druggist was started in MMC.

Related to industry

          The success of India is because of the manufacture sections, because of high growth rate and government policies and the overseas market.

           Many units in India were approved by the regulatory of USA and UK.

            1970- Patents act was established.

            1972- New patent act was established.

            At that time around 2000 to 24000 units of pharmaceutical university was started.

            Increase in sales was more than 9% per annum.

Related to organization

    1909- Bengal excise act.

    1912- United prevention of Adulteration act.

    1914- Punjab excise act.

    1919- Poison act was started and Adulteration Act was                     

              Started

    1926 – Bengal chemist and druggist Association.

    1923 – Qualified Pharmacist list was prepared.

    1930 – Dangerous drug.

CLINICAL RESEARCH INDUSTRY “A MODERATE 

      OUTLOOK”

       The Worldwide Pharmaceutical sales reached USD 1.3 Trillion in 2015 (-8%YOY increase) and are expected to reach. The emerging markets represent the fastest – growing segment of the global PHARMA industry. Sales in the growth will come from the emerging markets. The Indian PHARMA INDUSTRY is showing signs of healthy growth will come from the emerging markets.

Overall country attractiveness index

          China- 6.10

            India- 5.58

           Russia- 5.55

           Brazil- 5.26

           Czech Republic-5.00

           United Kingdom-5.00

           Argentina- 4.90

           Poland-4.84                                                                              

           Hungary-4.81                                                                                              

           Germany- 4.69

           South Africa- 4.56

           Taiwan- 4.46

           Israel- 4.28

           Singapore- 4.27

           Ireland-3.86

           United States-6.88

         

Pharmacopoeia

 It is an official book of standards. Applicable to drugs and their common dosage forms and pharmaceutical aid published in the country by the authority of its own government.

                     PHARMACEUTICAL CARRIER

PHARMACEUTICAL INDUSTRIES

           Production

          Manufacturing,

           Packaging,                                                                              

           Store and purchase,

           Quality control,

           Quality assurance

Pharmaceutical   marketing

Product management,

Hospital   and clinical pharmacy 

Conclusion

        India is one of the fastest growing economies of the world, and the Indian Pharmaceutical Industry has been an important constituent to the Pharmacy sector worldwide due to the recent changes in patent laws, the rising use of generics, high cost competitiveness, and availability of large scientific research force in the country.

      Strong GDP growth and significant cost advantages has resulted an in the Indian Pharmaceutical Industry to grow significantly at CAGR of 20%. Participation of Indian Pharmacy companies in the international pharmaceutical market has increased and with more generic products being introduced in developed economies, Indian formulation and bulk drug exports have grown significantly. Also, increasing cost pressure on innovators has resulted in significant growth in contract research business.