Maharashtra contributes substantially to the pharmaceutical sector of India. A large amount of the drugs and pharmaceuticals produced in the country are manufactured here.  It has  the maximum number of active pharmaceutical ingredients (APIs) units. Hence the  pharma industry  of the state has played a crucial role  in making  Indian pharmaceutical industry a global leader in  generic medicines.

Maharashtra has been a hub for the pharma industry, both in terms of manufacturing as well as supply of materials. It has been a rich breeding ground for innovation, a source of abundant skilled and diverse manpower which could effectively support the pharma sector in the past.

It is no surprise then that a majority of the top 10 pharma companies in the country are based in the state.  Due to Its economic strengths and  ideal logistics positioning, Maharashtra had a glorious past and continues to still house  major corporations across sectors.

According to a  Pharmabiz study, overall Indian pharmaceutical segment is dominated by Maharashtra - based entities on account of huge investment in facilities and new technology. They are now gearing up  to tap lucrative international markets like the US, Europe, Japan, besides emerging markets by investments in research, new cost -effective products and tie-ups. These players are building strong product pipeline through  higher approvals from regulated authorities.

These companies are adopting flexibility in operations and restructuring business activities to overcome several odds like competition, slowdown in global economy, expiration of patents, adverse exchange fluctuations and limited success from R&D area.

Besides these listed companies, there are several major unlisted and small and medium-scale companies contributing to the growth of pharmaceutical segment in Maharashtra. The overall better infrastructure facilities, connectivity, availability of talent pool and government policies are playing a positive role in development of this segment.

Many pharma companies  could be successful largely because their major operations are based in Maharashtra. The government support received by the industry has been substantial and the presence of a pragmatic and  stable state government has been one of the main reasons for the state to be a principal destination for all pharma companies whether Indian or MNC.

The Food and Drug administration of Maharashtra  established in 1959  is a vibrant and proactive organization with its headquarters in  Mumbai, with licensing authorities appointed at divisional places to approve manufacture of drugs. In order to safeguard and enhance public health by assuring safety, efficacy and quality of drugs and cosmetics, FDA is  taking a number of initiatives, says Mahesh Zagade, Commissioner of FDA.

One of the key driving forces that makes Maharashtra a perfect haven for the pharma manufacturers, is the highly active and organised distribution system present in the state. Having an organised drug distribution system is  essential to ensure delivery of drugs to even the remotest part of the country. It is the retailers, wholesalers and the distributors who actually make the concept of accessibility of safe medicines possible throughout the country. Thus their claim to be one of the key influencing factor in the supply chain management  system is  an undisputed one.

Says Narendra Jain, general secretary, Maharashtra Chemists & Distributors Federation (MCDF), “We closely work with the patients by ensuring that there  is no lacunae in the supply chain so as to ensure timely delivery of medicines to all, as it is the life of the patient is at risk. We have organised our business activities in such a way that we have our reach even to the remotest part of the state”.

Maharashtra has a thriving economy which is underpinned by a sound economic and social infrastructure. The economic infrastructure includes roads, airports, railways, ports, telecom and power. Education and training, tourism and health services are included in the social infrastructure.

The state is able to attract investments due to the availability of human capital, skilled labour, good infrastructure and government policies. The real strength of Maharashtra is in the availability of diverse skilled manpower such as pharmaceutical research scientists, pharmacology, pharmaceutical chemistry and pharmacists, microbiologists, analytical chemists along with management experts in manufacturing, marketing, finance, sales and  human resource development. All these experts in Maharashtra at par with international standards.

Despite these advantages, Maharashtra has  seen an erosion of pharma units during  the last decade. Several pharmaceutical units moved out of the state on account of  labour problems, power shortage, pollution problems, soaring real estate rates and lack of tax concessions.  

With the intensification of competition , many  units had shifted to neighbouring states or newly carved out states like Chhattisgarh, Jharkhand, Uttaranchal and Himachal Pradesh between 1995 and 2000 because of the massive concessions they were offered.

While in 1995,  70 per cent  of the pharmaceutical production in the country was from Maharashtra,  by the end of 2010, it had come down to a meagre 24 per cent.

Says Daara B Patel, Secretary-General, IDMA, the pioneering pharmaceutical industry in Maharashtra needs to be supported and assisted to reclaim its pre-eminent position in India. For this  the  government should encourage pharma industry to set up manufacturing plants in the state now that the tax/excise duty benefits in states like Himachal Pradesh, Uttarakhand, Jammu and Kashmir etc have been reduced. Maharashtra is definitely a more attractive state for pharma industry and companies would be eager to come back if the state offers attractive incentives, he pointed out.

The state government must also provide tax incentives and subsidies to the pharma industry. This would encourage newer players to enter into the fray and help more established ones to build on their foundations. New R&D units must also be set up to undertake R&D work for domestic and international companies, he added.

The state government must provide technical and financial assistance and support to enable the Common Effluent Treatment Plants (CETPS ) to perform optimally to ensure that effluents are treated at the same time the ensuing pollution is controlled. This would encourage more pharma units to set up CETPs, he opined.

According to him dedicated area/ zone must be earmarked / allotted to set up API industry with CETP, generators and other requirements. He has also suggested that more cluster-based projects must be encouraged by providing state-of-the-art common facilities.   WHO GMP certificates need to be granted quickly within set timeline as done in other states. Online submissions and approvals of additional products etc need to be encouraged to speed up the process, he added.

Existing units must be allowed to expand to meet growing domestic and  international demands. Octroi duty on all bulk drugs must be totally exempted in Mumbai, he emphasized.

According to him industry-academia interaction and closer co-ordination must be encouraged. A small committee needs to be set up with members from industry and government to frequently interact so as to suggest ways to encourage and expand pharma industry in the state .

Chiming in  Narendra Jain said  the stakeholders can perform and deliver better services in a more effective manner, if some of their  key issues are addressed properly.

Some of the key issues and demands that stakeholders from the state have been demanding are objection over the inclusion of Schedule HX. All the associations have been unanimously objecting to the governments decision to amend The Drugs & Cosmetics Rules 1945 and insert Schedule HX on misuse of antibiotics, he said.

Maharashtra State Chemists & Druggists Association (MSCDA)  and  Maharashtra Chemists & Distributors Federation (MCDF), two of the most important associations in the state have already sent many representation to the state government which is yet to get any response. Other issues they have been objecting over are the ongoing controversy over the dispensing of medicines by doctors, pricing of the essential medicines etc.

To address these issues the state government had recently constituted a core team consisting of FDA officials and key stakeholders. This committee is set up with a view to address key issues faced by the stakeholders in the state and to build up a more responsive relation between the state regulatory body and the stake-holders.

Maharashtra would definitely regain its numero uno status if proper incentives are offered to the manufacturers and a  strategy  is worked out to ensure that the state retains its former position in the sector, says Mahesh Zagade. Hence the state  pharma sector is badly  in need of a booster shot to revive its sagging fortunes.