Fact Sheet

    The Pharmaceuticals industry in India today is one of the largest and most advanced among the developing countries. Indian Pharmaceuticals Industry manufactures bulk drugs belonging to several major therapeutic groups requiring various manufacturing processes and has developed excellent facilities for production of all dosage forms like tablets, capsules, liquids, orals and indictable etc. This achievement is strengthened by an assurance with regard to quality of the products. Over the last several years, policy inputs have been directed towards promoting the growth of the industry and in helping it to achieve a broad base in terms of the range of the products and technologies needed to produce them from as basic stage as possible. The result has been very encouraging. As on date, there are about 250 large units and about 8000 Small Scale Units in operation which form the core of the industry (including 5 Central Public Sector Units). These units produce the complete range of formulations i.e. medicines ready for consumption by patients and about 350 bulk drugs i.e. chemicals having therapeutic value and used for production of formulations. Today, India is in a position to meet 70% of the country’s requirement of the bulk drugs and almost all the demands for formulations. The setting up of the Penicillin factory At Pimpri, Pune in the early 1950’s and the construction of Indian Drugs and Pharmaceuticals Ltd. (IDPL) plants at Rishikesh and Hyderabad in 1960’s are important milestones in the history of the pharmaceutical industry in the country and public sector investment in the pharmaceutical industry in the initial stages played the role of a catalyst in the development of the industry in the last three decades.

    The following table shows the value of production of bulk drugs and formulations from 1990-91 to 1997-1998.

Rs. In crores.

    From a meager Rs.46 cores worth of pharmaceuticals exports in 1980-81, the exports have risen to Approx. Rs. 6152 Crores (Prov.1998-99).

    The details of the exports of Drugs,Pharmaceuticals & Fine Chemicals during the last three years are as follows:

During April 1998-March 1999, total exports amounted to Rs. 6152.22 crores, which was 13.52% higher than the performance during 1997-98.

In accordance with the information available from D.G.C.I.S. imports of medicinal and pharmaceutical products for the last three years have been as under: -

    There have been no reports of shortage in recent years. As already indicated the country is almost self-sufficient in case of formulations required by the consumers. It may also be mentioned that industrial licensing for most of the drugs and pharmaceuticals products have been done away with. The manufacturers are free to produce any drug duly approved by the Drug Control Authority.

    Imports of drugs and pharmaceuticals are allowed freely, excepting those in the restricted list of import under the current EXIM Policy, which can be imported under an import licence. In view of these steps, no shortage of medicines is likely to occur. Import can take place from any part of the World, there being no general restrictions.

    The Working Group on drugs and pharmaceuticals for the Ninth Five Year Plan period (1997-98 to 2001-2002) has worked out future growth rate as follows:

1. Growth rate for domestic consumption of formulations as 15%;
2. Growth rate for exports of formulations as 10%.
3. Growth rate for exports of bulk drugs as 20%.
4. Growth rate for bulk drugs production as 20%.
5. Imports of bulk drugs (CIF value) be restricted to 12% of the total value of bulk drug requirement;
6. Growth rate for the total bulk drug requirement for exports and form formulation activity (for both domestic consumption and exports) as 16%;
7. The ratio of value of consumption of bulk drugs for production of formulations to the value of formulations produced as 1:4.

    It may be stated that no country can become entirely self-sufficient in case of pharmaceuticals. Therefore, imports are expected to continue even with the advance level of technological inputs. Import of a drug would be dependent upon a variety of factors like incidence of disease for which it is used, feasibility of its production in the country or, if already being produced, status of its current indigenous production, availability of alternate/equivalent drugs, international price vis-à-vis price of indigenous produce, tariff rates, import policy etc.

    The Department of Science and Technology has a dedicated programme for promoting R&D in the drugs and pharmaceutical sector. A two-tier structure exists to manage the programme viz. An Apex Executive Committee at the Secretariat level, chaired by the Secretary, DST and an Expert Committee at the operational level.

    To be globally viable in R&D, high-level expertise and adequate human resources as also modern facilities in specified areas of drug developments are required. It was, therefore, decided that the DST Programme, besides new drugs development projects, should also support creation of facilities that are essential for new drugs development. Accordingly, facilities that are needed urgently and that would need to be created, namely, (a) DHA gyrase screening facility; (b) Quantity-Structure-Activity-Relationship (QSAR) facility; (c) immunomodulators modeling and screening and (d) Pharmacological testing were identified. Under the said programme 34 proposals have so far been cleared. In the Department of Chemicals and Petrochemicals, a Budgetary provision of Rs.16 lacs exists for the year1999-2000 to fund R&D projects and R&D related studies in the pharmaceutical sector.

    As per the Resolution, the National Pharmaceutical Pricing Authority (NPPA) was established on 29.8.19997 with a view to enforcing the provisions of the Drugs (Price Control) Order (DPCO) and to perform the functions assigned. Upto 19.11.1999 the following actions/steps have been taken by NPPA since its inception:

1. During the year 1999-2000 (April 1999 till 19.11.99) revised/fixed the prices of 17 scheduled bulk drugs and derivatives (10 bulk drug plus 7 derivatives) and 187 formulations packs.
2. NPPA vide its order published in the Gazette of India Extra Ordinary dated 27^th January, 1999, has asked the manufacturers of all the Scheduled formulation pack sizes to work out the prices of different pack sizes of the tablets and capsules of the same strengths or composition packed in different strips or blisters on pro-rata basis of the latest ceiling price fixed. This was done to ensure that (i) The manufacturers do not change their pack sizes in bid to remain out of price control and (ii) manufacturers are not forced to approach the Government/NPPA frequently for price approvals of different pack sizes.
3. Compiled the data on production of selected/monitored bulk drugs and imports of bulk drugs for the year 19998-99.
4. Analysed price movement between January 1994 and March 1999.
5. Fixed the prices of three commonly used I.V. Fluids by exercising the powers available under Para 10(b) of DPCO, 1995. These prices are lower by about 40% than the prices charged earlier by the companies from the consumers.
6. To keep a check on the prices of the drugs, besides advising the State Government to enforce the prices of scheduled formulations, NPPA held a MEETING AT New Delhi with the State Drug Controllers on 25^th Aug. 1999.
7. NPPA advised the States and Union Territories to nominate/set up nodal officers/monitoring cells to enforce/monitor the prices and availability of medicines.
8. NPPA notified the norms of conversion cost (CC) packing charges (PC) and process loss (PL) vide S.O. 578 (E) dated 13^th July 1999.
9. Overcharging cases were pursued vigorously by NPPA and as a result, an amount of Rs. 327 lakhs was recovered from the companies on account of overcharging.
10. NPPA launched its website on 11^th Jan., 1999. It is accessible at www.nppaindia.com. All price notifications issued by NPPA, Drug policy, DPCO, 1995, notified norms etc. are available on the website.
11. One of the functions of NPPA is to render advice to the Central Government on changes/revisions in the Drug Policy. The Government constituted a Drug Price Review Committee on 18^th March 1999 to review the current Drug Price Control Mechanism and suggest alternative models among other things. Another Committee viz. Pharmaceutical Research and Development Committee was also constituted by the Government on the same date to recommend measures to strengthen the research and development capability of the pharmaceutical industry in the country and to identify the support required by the Indian Pharmaceutical companies to undertake domestic R&D. Chairman, NPPA is one of the members in each Committee. NPPA, being an expert body, rendered expertise to both the Committees besides providing inputs and various data.

    An Export Promotion Cell in the Pharmaceutical Division has been created with the objectives of boosting pharmaceutical exports and to Act as a nodal centre for all queries/issues regarding pharmaceutical exports. The Cell also undertakes promotional activities for acceleration of pharmaceutical exports and considers suggestions for modifications in EXIM Policy from the industry. The Cell has also been entrusted with the organisation of seminars and workshops on standards, quality control requirements etc. of important countries so as to prepare the domestic companies for exporting their products. During April’ 99, a team of Russian experts visited India to explore the possibility of accreditation of Indian Testing Laboratories for pre-shipment inspection of pharmaceutical exports. The experts visited several Indian Testing Laboratories located in different parts of the country. The occasion was utilised to organise a Seminar on the new drug registration procedure introduced in the Russian Federation. Consequent to the visit of the expert team, 13 reputed Indian Companies have been exempted from batch by batch testing for the purpose of export of pharmaceuticals to the Russian Federation.