R&D Scenario in Indian Pharmaceutical Companies

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RESEARCH AND DEVELOPMENT SCENARIO IN INDIAN PHARMACEUTICAL COMPANIES

SUBMITED BY:
MR. SHAMSHAD AH
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT

DEPARTMENT OF PHARMACEUTICAL MANAGEMENT
NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH
SEC. NO. 67, S.A.S. NAGAR MOHLI PUNJAB

CONTENTS:

* OBJECTIVES....................................................................................3 * INTRODUCTION.............................................................................3 * STRENGTHS AND WEAKNESS OF INDIAN PHARMA COMPANIES……………………………………………………....4 * CHANGING TRENDS IN R & D………………………………....5 * WAYS OF FUNDING FOR R & D…………………………….....8 * RESEARCH OPTIONS FOR INDIA………………………..........9 * THERAPEUTIC AREAS OF NEW DRUG RESEARCH & DEVELOPMENT.............................................................................9 * ROLE OF PUBLIC SECTOR…………………………………....11 * FOREIGN INVESTMENT IN R&D.............................................13 * EMERGING R&D STRATEGIES IN PHARMACEUTICAL SECTOR..........................................................................................15 * THE KEY ELEMENTS OF CREATING ECOSYSTEMS…...…20

* CONCLUSION…………………………………………………...20 * REFERENCES…………………………………………………..20

1. OBJECTIVES
One objectives of the post-1994 policy regime was the incentivisation of pharmaceutical research and development (R &D). Innovative products were given exemption from price control; a number of financial scheme were made available to firms for undertaking R&D; technology collaboration were brought under the automatic approval route; and most importantly, patent rights were granted for a period of 20 years for products as well as processes so what were the outcomes of these measures? Who are the major players? What are the therapeutics areas in which the R&D efforts are focused?

2. INTRODUCTION
An important aspect of the policy reforms in the Indian economy since 1991 has been the change in the perception on the respective roles of the public and private sector industries. In the pre-liberalisation phase, public sector industry in the pharmaceutical sector was assigned the leadership role and the private sector was required to support the efforts of the State. In the liberalisation phase the public sector is assigned with inferior position and the leadership role is assigned to the private sector firms who are also expected to make commercially sensible decisions.

The Industrial Policy Resolution of 1956 classified industries into three categories based on their priorities. “Schedule A” industries were exclusively reserved for the public sector and “Schedule B” consisted of industries, where the public sector would play a lead role and the private sector was expected to supplement the efforts of the State. “Schedule C” consisted of the remaining industries whose future development was left to the private initiatives. The pharmaceutical industry fell under Schedule B.

The Government of India established five public sector companies in India of which two played very important roles - Hindustan Antibiotics Ltd. (HAL) and Indian Drugs and Pharmaceuticals Ltd. (IDPL). IDPL was established with technical assistance from USSR and HAL with the technical assistance of World Health Organisation (WHO) and United Nations International Children’s Emergency Fund (UNICEF).

The public sector research laboratories under the Council for Scientific and Industrial Research (CSIR), especially Central Drug Research Institute (CDRI), Indian Institute of Chemical Technology (IICT) and National Chemical Laboratory (NCL) also contributed considerably to the growth of the Indian pharmaceutical industry. Their contribution has been in the form of development of laboratory level processes that were transferred to private industry, which scaled up the technologies at the industry...
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