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API units seek more sops for bulk drug sector revival

Mayuri Mathur
Thursday, December 31, 2020, 08:00 Hrs  [IST]

The active pharmaceutical ingredient (API) units of Maharashtra have appealed to tweak norms for revival of the bulk drug sector and have urged the state government to be more proactive in terms of incentives, tax sops and investment norms. The industry has suggested a three-pronged strategy to be adopted by the state government to address the adverse environmental issues.

Considering these proposals, the API industry in Maharashtra is looking forward for revision and relaxation of environmental norms for its revival in the state. Besides this, the industry is eyeing for permission to establish external effluent treatment facilities separate from manufacturing plants where untreated effluents can be sent by pipeline/tankers.

It is also expected that the existing common effluent treatment plants (CETPs) will be made functional so as to free the individual units from total treatment. Though there are pharma clusters in Thane, Nashik and Aurangabad, more cluster-based projects providing latest common facilities are awaited which will surely help the SME sector share costs and enhance quality, productivity and innovative capabilities of the pharmaceutical manufacturers.

Recently, Maharashtra government has decided to set-up a single-window system to grant clearances and address the grievances of various pharmaceutical companies in order to attract and satisfy the demands of these market players. The Government of India has unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has also been reduced to boost investments.

Growth drivers
The rapidly increasing rate of persistent infections along with the rising importance of conventional drugs have nudged the Indian API market to grow positively. The promotion of API via clusters and Production Linked Incentive (PLI) programs initiated by the Government of India has also drastically changed the market dynamics. Low labour cost, abundant availability of raw materials, infrastructure facility, rise in generic drugs demand, increased production capabilities, the presence of a large number of domestic and international players and concentration of CMO companies are some of the other factors that are driving the market growth.

API is an important segment of the Indian pharma industry, contributing to around 35 per cent of the gross market. While the Indian pharmaceutical market grows at twice the GDP, the growth of pharma sales in Maharashtra is observed to be above the industry average.

Maharashtra is deemed to be a leader in vaccine production and a number of Special Economic Zones (SEZs) have been notified within the state for its sustenance. In addition to this, a large chunk of pharma products and API’s are manufactured and exported from the state which has been instrumental in driving the growth of pharma industry in India. Hence, Maharashtra is considered as the capital of the pharma industry in India with more than 3,000 pharma units successfully established within its geographical precincts. Moreover, the state has the capability to attract R&D investments in the new research areas and take appropriate steps to extract this opportunity optimally.

The Indian drug industry is the world’s third-biggest as far as volume is concerned and thirteenth biggest industry in terms of value. According to global market estimates, the Indian API market is expected to grow rapidly at a CAGR of 8.57 per cent in the upcoming years and may reach approximately US $ 238.8 billion by FY 2025-26.

State pharma industry
Maharashtra’s contribution to the Indian pharma market is substantial as it contributes to more than 11per cent of the country’s total pharma market value. The state is home to 347 bulk drug units, 693 formulation units and numerous manufacturing units which include nine vaccine units, 17 large volume parenteral units and about 1,200 ayurvedic and cosmetics units. Presently, Maharashtra has 171 units approved as per World Health Organisation’s Good Manufacturing Practices (WHO-GMP) guidelines and 10 units approved by the United States Food and Drug Administration (FDA).

Maharashtra has always remained the industrial and financial hub of India. The governing body of Maharashtra, FDA, is highly structured and organised and has good technical hands facilitating appropriate support to the pharma market players. Various industries started their operations in the state and grew substantially due to the conductive atmosphere for growth and favourable government policies. Today, almost all major pharma companies in India have their headquarters in Mumbai and several pharma firms and API manufacturers have chosen Maharashtra as a centre point due to its advantageous location for smooth distribution across various parts of the country.

The port facilities in the state are well equipped with latest technologies having advantage over the ports in other parts of India. The custom clearance process is highly atomised through Electronic Data Interface (EDI), which facilitates smooth clearance of import and export shipments. Along with good infrastructure and ease of doing business, the state also has the advantage of skilled manpower. This diversely skilled manpower supply is essential to maintain the international standards of manufacturing which are in parallel with regulatory guidelines worldwide. India has the highest number of US FDA approved plants majority of them located in Maharashtra.
Regulatory aspects
The Drugs and Cosmetics Act of 1940 and Drug and Cosmetics Rule of 1945 form the basis of import, distribution, manufacture, quality checks and sales of drugs in India. Later, various revisions and amendments have been considered and implemented leading to the present-day state of regulations. Major among these is Pharmacy Act 1948, The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, Indian Patent Act 1970, Trade Marks act 1999, Drugs Price Control Order, 1995 (DPCO), Uniform Code for Pharmaceutical Marketing Practices (UCPMP) and Research and Development Cess Act, 1986. These have, directly or indirectly, impacted this sector and are largely responsible for the growth or hurdles for various pharmaceutical and API manufacturers in India till date.

At present, drug regulations are segmented into two bodies i.e., the Central Drug Authorities and the State Drug Regulatory Authorities (DRA). The Central Drugs Standard Control Organization (CDSCO) is the apex national drug regulatory authority for carrying out the responsibilities allotted to the Central Government in accordance with the D&C Act, while the State DRA controls the state level affairs. Besides CDSCO and State regulatory agencies, The Drug Controller General of India (DCGI) and National Pharmaceuticals Pricing Authority (NPPA – 1995), are equally conscientious to support this industry by regularizing the norms and keeping a check on the pharmaceutical market.

The regulatory infrastructure in Maharashtra is of the highest order and the percentage of substandard drugs produced in the state is far lesser compared to other states. The administration of drugs in Maharashtra is vested with food and drug administration, which strives to enforce the relevant acts in a fair manner by upholding the safety standards and protecting consumers through it. Maharashtra is the first state to set up an independent Intelligence Branch with a separate wing to facilitate and speed up investigations under acts enforced by the FDA.

Blockers and impediments
Indian pharma market is one of the fastest growing markets after China. We are prominent in terms of demand but when it comes to the manufacturing of API and generics, we are somehow struggling in getting approvals, maintaining international quality, GMP and more. The policies and laws are copiously formulated but lack in effective implementation creating the gaps in this complex market. There are serious raw material supply disruptions and pricing volatility in the Indian marketplace which creates uncertainty for the market players.

Apart from these, the state suffers its own roadblocks. There are some labour policies, pro-labour laws and attitude of the state government which has played as an antagonist. The procurement of licences for new justified formulations is difficult with respect to the other states of the country. Other issues such as octroi, which has not been removed till date, is both money and time-consuming, interrupting the smooth functioning of pharma industries in Maharashtra. Adding more to this, Mumbai, which is a major hub for pharmaceuticals, is expensive and has also taken its toll on the industry. Due to these barriers the market players are exploring the other parts of the country for their smooth functioning and favourable operation.

Certain tax and excise exemptions offered by industrially backward states such as Himachal Pradesh, Uttarakhand, Baddi, Jammu and Kashmir are also resulted in a large number of industries shifting their manufacturing facilities outside Maharashtra. According to IDMA, the saturated infrastructure and traffic problems in Maharashtra, especially Mumbai, are acute and the progress is slow which is forcing people to think of other states that are more economical in terms of property costs/rentals, cost of living and overall business expenses including wages.
The road ahead
India needs a holistic and conducive ecosystem to capitalise on the full potential of its API manufacturing capabilities, which can include some immediate-term interventions and a few long-term ones. Maharashtra can look forward to an increase in the number of pharma manufacturing facilities, provided appropriate incentives and assistance is offered.

The Maharashtra FDA should strengthen its technical wing and make judicious decisions in order to hold the pharma and API manufacturers within the state limits and attract the new market players. Now that the period of the tax incentives given by other states is almost over and after reaping the advantages of tax and excise incentives, many pharma companies are again looking at the state. Maharashtra can reclaim its premier role as the torchbearer for the Indian pharma sector with a little help from the government and attain new heights in the indigenous as well as global pharmaceutical market.

(The author is freelance pharma consultant)


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