Out of the 20,000 odd pharmaceutical units in the country, about 3,800 are located in Maharashtra, according to the state FDA. These large, medium and small manufacturing units are concentrated in Mumbai, Thane, Palghar, Nashik, Aurangabad and Pune. Turnover wise, over Rs. 8,000 crore (40 pc) out of Rs. 20,000 Indian pharmaceutical industry comes from Maharashtra.
The state comes third in active pharmaceutical ingredients (APIs) manufacturing. Figures show that the pharma industry in Maharashtra is growing at a pace of 10-15 per cent per annum.
Mumbai exports almost 70 per cent of APIs and about fifty per cent of formulations produced in the country. Ranbaxy, Dr. Reddy's Labs, Sun Pharma, Lupin, Cipla, and J B Chemicals are among the leading exporters from Mumbai. Out of top ten companies, four companies and corporate offices of the leading companies are located in Maharashtra.
Although no official figures are available on exports, experts estimate its growth rate at 15 per cent. The 36 districts of Maharashtra together grabs around 20 per cent of the total retail trade in the country, which works up to the tune of Rs 4,000 crore. The Maharashtra State Chemists and Druggists Association (MSCDA) has got the distinction of being the only trade body representing 35, 000 retail pharmacists in the state. Maharashtra is the first state to adopt integrated approach as regards to monitoring the quality of both food and drugs. In 1970, Directorate, Drugs Control took over the responsibility of implementation of the Prevention of Food Adulteration Act, 1954 and the name of the department was changed from Drugs Control Administration to the Food and Drug Administration, Maharashtra State.
FDA discharges its responsibilities through strong work force of 1,335 spread throughout the state. The state FDA has a well-equipped and independent drugs control laboratory. The Assistant Director heads the drugs control laboratory and Scientific Officers assist him.
The laboratory receives samples of drugs and cosmetics from the Drug Inspectors in Maharashtra and Goa. The present testing capacity is 6,000 samples per year. Recently, an additional laboratory has been set-up at Aurangabad. The laboratory has facilities to test different categories of drugs: chemical as well as biological. The system of coding of the samples has been introduced with a view to ensure that the analyst does not know the identity of the manufacturer and samples are tested in unbiased manner.
The 35,000-odd retail pharmacists in the state and a few wholesalers come under Maharashtra State Chemists and Druggists Association (MSCDA). The trade body is an affiliate to All India Organisation of Chemists and Druggists (AIOCD)-the umbrella organisation that represents nearly 5.5 lakh chemists all over the country including the Union Territories. MSCDA comes fourth in the country in terms of member strength after UP (65,000), West Bengal (55,000) and Bihar (45,000) and is responsible for 20 per cent of country's retail business to the tune of around 4000 crore. The state trade is estimated to grow at the rate of approximate 10 per cent per year.
Pharmaceutical Education in erstwhile Bombay State dates back to 1943 with introduction of 2 years BSc (Tech) in Pharmaceuticals and Fine Chemicals programme at UDCT, Matunga. Today, there are 9 Universities in Maharashtra viz., Mumbai, Pune, Shivaji, Amravati, Nagpur, North Maharashtra, SNDT, Marathwada Dr. Babasaheb Ambedkar University and Swami Ramanand Teerth Marathwada University. Number of degree colleges in the year 2003 were 52 out of which 10 were recognized as PG institutes.
In case of degree & PG Pharmacy Institutions, both the affiliating and examination conducting body is a concerned University. In the past, till 1984, the degree course was of 3 years duration after XII std in Science, the admission being restricted to candidates who have passed XII Science with Physics, Chemistry, Biology, Mathematics and English with minimum 50 per cent marks - which was changed to 4 years duration in line with AICTE's recommendation.
There are 67 diploma institutions in Maharashtra. The standards of these are controlled by Pharmacy Council of India (PCI), the affiliating body is Director of Technical Education and the exams are conducted by Board of Technical Examination. Both are government authorities.
There are dark shades however to this bright picture. The state has fared poorly on the GMP front. As per the information revealed by FDA sources till August 2003, only around 110 out of 3,000 allopathic units and 130 out of 819 Indian System of Medicine (ISM) units in the state so far have been granted Schedule M and Schedule T certifications respectively complying with 'WHO-GMP' certification norms.
The deadline for Schedule M compliance will expire on December 31, 2003 and for the Schedule T has already expired in May 2003. The authorities are confused about any future extension.
Seeing the state lagging behind others like Andhra Pradesh and Karnataka in biotechnology initiatives, Maharashtra government came strong with its biotech policy during late 2001. Following its policy, state government decided to set up a pharma biotech park at Hinjewadi in Pune with 136-acre area and an Agro biotech park at Jalna with 100-acre area. In its 20-page policy document, the state government has announced a three-point strategy to boost biotech investments in the state.
A Maharashtra Biotech Board has been set up with chief minister Sushil Kumar Shinde as its president and eminent people from science and technology and industry as members.
A 13-member Maharashtra Biotech Commission has also been set up with Dr. R.A. Mashelkar as its Chairman and leading scientists from leading institutions and industry.
Enshrined in the Maharashtra Biotech Policy are tax sops for setting up biotech units in the state. A lower tax rate under the value-added tax regime, twice the existing floor space index (FSI) for biotech units, exemption from stamp duty and registration fee and 30 per cent of the fixed capital investment are some of the financial incentives and tax benefits to those who set up biotech units in Maharashtra. Under the new policy, biotech units can be set up in all regions of the state and will be eligible for incentives allowed for the state's second least developed regions.
Units set up in regions where development has already occurred (B, C and D) regions would be eligible for a second tier of incentives. These include capital subsidy for small-scale biotechnology units and refund of octroi and similar levies. Apart from this, the draft policy promises that twice the admissible FSI would be given to units in parks promoted by the MIDC and other public bodies and other yet to be designated locations.
New units and the subsequent expansion of existing units will be exempted from payment of stamp duty and registration fees in the developing and backward regions of the state. In other areas such exemptions would be extended to units in biotech parks promoted by public bodies. In private parks, 50 per cent of such stamp duty and registration fees would be waived. In addition, only 10 per cent of the admissible stamp duty would be payable on property transactions resulting from amalgamation of biotech companies.