The drugs and pharmaceuticals industry in India has shown phenomenal progress during the last four decades. So much so that India is in a position to meet 70 per cent of its requirement of bulk drugs and almost all its requirement of formulations. In fact, the country is almost fully self- reliant in terms of formulation technology.
In the case of bulk drugs, the technologies include those for sylph drugs, vitamins, hormones, pencillin, rifampicin, and a number of new synthethetic drugs like flumeguine, pefloxacin, ramipiril, ketorolac and lisinopril etc.
The value of drugs and pharmaceuticals produced during 1993-94 was about Rs. 1,320 crores as compared to Rs. l2croresin 1947-48. During 2000- 01, the production of bulk drugs and formulations has been of the order of Rs. 4,000 crores and Rs. 20,000 crores respectively, showing a growth rate of 83 per cent and 91 per cent respectively over 1996- 97. Table 22.V displays the production trends of drugs and pharmaceuticals in the country between 1987-88 and 2000-01.
The drugs and pharmaceutical units in India are mostly located in Maharashtra, Gujarat, Tamil Nadu, West Bengal, Madhya Pradesh, Rajasthan Uttar Pradesh and Delhi. The important centers are Mumbai, Kolkata, Ahmadabad, Vadodara, Delhi, Pune, Rishikesh, Indore, Jaipur, Hyderabad and Kanpur etc.
About 250 units in the organised sector, five in the public sector (IDPL, SSPL, HAL, BCPL, and
BIL), six in the joint sector and about 5,000 units in the small scale sector are engaged in the production of drug and pharmaceuticals. Of these, more than 100 are engaged in the production of bulk drugs. The industry gives employment to more than 3 lakh people. Most of the units have been set up in collaboration with pharmaceutical firms of UK, USA, Switzerland, Italy and Germany. The leading public sector companies are Ciba, Sarabhai, Hoeschst, Alembic, Unichem, Bengal Chemicals, Glaxo, Pfizer, Chemo Pharma and Warner Hindustan.
Indian Drugs and Pharmaceuticals Limited (IDPL) incorporated under the Companies Act, 1956 on April 1961, is a premier undertaking. The company has five plants including two wholly-owned subsidiaries-one each located at Rishikesh (Uttaranchal), Hyderabad (Andhra Pradesh), Gurgaon (Haryana), Chennai (Tamil Nadu), and Muzaffarpur (Bihar). IDPL has also set-up three subsidiary companies in collaboration with the respective state governments for production of quality pharmaceutical formulations. These are: Rajasthan Drugs and Pharmaceuticals Limited (RDPL), Jaipur; Uttar Pradesh Drugs and Pharmaceuticals Limited (UPDPL), Lucknow, and Orissa Drugs and Chemicals Limited (ODCL), Bhubaneswar.
The antibiotiotics plant at Rishikesh is one of the largest in the world producing seven antibiotics on a mass scale. Synthetic Drugs Plant, Hyderabad produces a wide variety of drugs, sulphas, phenacetin analgesics, vitamins and anti-TB drugs, metamizol and piperazine salt. Surgical Instruments Plant, Chennai manufactures different types of surgical instruments, besides intra-uterine contraceptive devices and vasectomy instruments.
Hindustan Antibiotics Limited (HAL) incorporated on March 1954 was the first public sector undertaking in the field of pharmaceuticals. The company was set up primarily with the objective of manufacturing pencillin and other antibiotics. It also produces streptomycin, haymycin and autofungin, besides formulation. HAL has three subsidiary companies, promoted in collaboration with the respective state government, Karnataka Antibiotics and Pharmaceuticals Limited (KAPL), Bangalore;
Maharashtra Antibiotics and Pharmaceutical Limited (MAPL), Nagpur and Manipur State Drugs and Pharmaceuticals Limited (MSDPL), Imphal.
There are three public sector undertakings engaged in the manufacture of drugs and formulations located at Kolkata (West Bengal). These were private sector companies taken over by the Central Government. Bengal Immunity Limited (BIL) is the producer of SERA and vaccines toxoids.
It also produces other pharmaceutical formulations. Bengal Chemicals and Pharmaceuticals Limited (BCPL) with four manufacturing units is the largest producer of anti-snake venom in India. It also produces chemicals like sulphuric acid, alum, chrome salts, herbal products and home products like soaps, hair oil, perfumes, etc. The Smith Stan street Pharmaceuticals Limited (SSPL) is engaged in the manufacture of pharmaceutical formulations.
The Hindustan Organic Chemicals Ltd., Rasayani (Maharashtra), set up in 1960, produces various organic chemicals and intermediates required by drugs, dyestuffs and plastic industry. The Hindustan Insecticides Ltd, New Delhi, incorporated in 1954, produces insecticides like D.D.T. And BHC (at Alwaye). The Government of India has set up the National Institute of Pharmaceutical Education and Research (NIPER) at Mohali (near Chandigarh) to carry on research and training in pharmaceuticals.
India imports drugs and pharmaceuticals from USA, UK, Germany, Switzerland and Canada, etc. The value of import has risen from Rs. 105.58 crores in 1988-89 to 1152.10 crores in 2002-03. It also exports drugs and pharmaceuticals to many countries like UK, Russia, USA, Germany, France, Italy, Spain and Australia. During 1988-89 India exported Rs. 355.74 crores worth of pharmaceutical products which increased to Rs. 6,779.11 crores in 2002-03. Some important items of export include quinine slats, strychnine and bromine slats, emetine alcoholics, castor oil, homeopathic medicines, ointments and proprietary patent medicines.
The salient features of the modified drug policy (1986) as announced on the 15 September 1994 are: (i) Abolition of Industrial Licensing for all bulk drugs, their intermediates and formulations thereof except five bulk drugs of the public sector, (ii) Foreign investment up to 51 per cent will be automatically permitted in the case of all bulk drugs, their intermediates and formulations; (iii) Automatic approval for foreign technology agreements shall be given in case of all bulk drugs, their intermediates and formulations, except those produced by the use of recombinant DNA technology; (iv) Measures to give further impetus to R & D in the drug sector : (a) newly developed drug would be put outside price control for a period of 10 years, (b) Deptt. of Chemicals and Petrochemicals to set-up inter-ministerial group to decide, within a set timeframe, on measures to give further impetus to R & D in the drug sector, and (c) Ministry of Health and Family welfare to take suitable steps for the quick clearance of new drug applications, especially those developed through indigenous R&D.
(v) The system, of price control would be operated through a single list of price-controlled drugs, selected on the basis of transparent and objective criteria as laid down in the ‘modifications in drug policy 1986 and formulations based thereon with a MAPE of 100 per cent; (vi) In case of basic manufacture, the rate of return would be higher by four per cent over the existing rates which are 14 per cent on net worth or 22 per cent on capital employed;
(vii) To achieve uniformity in prices of widely used formulations there should be ceiling on prices for commonly marketed standard pack sizes of price controlled formulations; (viii) National Pharmaceutical Pricing Authority to be entrusted with the task of price- fixation/revision and other related matter; (ix) Government to keep a close watch on the prices of medicines which are taken out of price control; (x) A National Drug Authority to be set up to look after the) quality control aspects, rational use of drugs and related matters; and (xi) To provide better focus to all matters relating to developing and promotion oil indigenous and other systems of medicines, a separate Department would be created by the Ministry of Health and Family Welfare.