Gujarat pharma industry is now fast developing into an ideal contract manufacturing hub. The key strengths of this state are established pharma industry, entrepreneurial mindset, well-developed allied industries and favourable regulatory environment. There is also considerable momentum in the setting of modern infrastructure facilities and backward linkages with raw material suppliers .
According to Manoj R Vora, Alvita Pharma Private Ltd, Gujarat holds huge potential on the manufacturing front. This is despite the fact the state has many production plants which are old and are badly affected due to migration of drug manufacturing to the former excise free zones like Baddi in Himachal Pradesh and other regions.
Therefore the existing manufacturing facilities need upgradation as per cGMP guidelines. However the newer units are implementing the latest production technology and meeting cGMP for exports to ROW (rest of the word )and regulated markets. Though Gujarat still remains the hub for manufacturing products for exports, it has lost domestic edge, he added.
Opportunities for growth
Gujarat has the potential to be developed into an ideal location for global clinical research and be a competitor in CRAMS (contract research and manufacture services). Further, the state will also have to capitalize on emerging opportunities such as medical tourism, contract research and pharmaceutical machinery manufacturing. Key to this process will be-building global competitiveness, developing a strong talent pool and adopting a conducive global mindset, as per a KPMG report.
The opportunities in the state are ensuing from the special economic zones (SEZs) led export opportunities. There are huge promising prospects in segments such as CRAMS, R&D and generics.
Some of the leading companies with advanced plants in Gujarat are Sun pharma, Zydus Cadilla, Intas pharma, Torrent Pharma, Troikka pharma, JB pharmaceuticals, Elysium pharmaceuticals, Amneal Pharma, Gufic Lifescience, Nirma , Claris Life sciences, to name a few.
“Gujarat is a progressive state and there are several units that have successfully gone through global regulatory audits. The state’s Food Drug Control Administration (FDCA) has ensured technology adoption and implemented all clearances online. In fact other state drugs control departments have been asked to take the support of Gujarat FDCA as a consultant to deploy online solutions. The framework is viewed as an ideal model for online information access and approvals efficiently and at a faster pace,” said Kaushik Desai, pharma consultant.
The state is also ideal for contract manufacturing because of its excellent infrastructure in terms of roads, rail and air making transportation convenient and quick, added Desai. A big challenge is for the small and medium enterprises in the state to adhere to the revised guidelines issued by the CDSCO in Good Laboratory Practices and cGMP.
Chiming in with the pharma industry expert, Vora said the major challenge to succeed in Gujarat is to upgrade to the new cGMP guidelines as in other regions where plants are newer and automatically better equipped. The research scene is not very good in Gujarat compared to other states in India. This activity is limited to large companies like Sun Pharma, Intas, Zydus Cadila . The only midsize company which is innovative is Troikka.
Investor friendly destination
The state is the best destination for investment mainly from a policy perspective as the state government has been focusing on pharmaceuticals as among the growth drivers. There is access to labour and availability of skilled personnel is at reasonable costs. In order to man and administer pharmaceutical operations, qualified workforce is needed to ensure the state is industry friendly with an efficient administration to attract potential investments not just from India but from global arena. However, the only weakness is the lack of fluency in English leading to hassles during regulatory documentation submission pointed Vora adding that it is easy to get the right manpower to work in the in the pharma sector of Gujarat.
Most of the units are currently focused on exports , as domestic manufacturing is not viable. Moreover only products coming under the purview of DPCO (drug price control order ) are manufactured in Gujarat. With the implementation of the Good & Services Tax (GST) this state can be a leading manufacturing hub for pharma, noted Vora.
Another issue here is the high MRP(maximum retail price). This has seen products to be manufactured being shifted to other regions for price advantage and this is why the major focus of Gujarat remains exports. The biggest challenge is to develop new products and get them manufactured outside Gujarat due to distinct price disadvantage for domestic market.
Gujarat is excellent in contract manufacturing and the facilities here are seen to have adhered to stringent regulations. However, there have been disadvantages because some companies have lost orders to manufacture high value products which have moved to production units in the subsidized regions.
Gujarat is preferred as an investment hub by leading pharma majors primarily for exports. This is attributed to the better administration, easy availability of manpower and proximity to ports and airports making overall costs cheaper compared to other destinations.
The state is known for both high value and volume in pharma machinery and equipment which have been recognized by global companies. They sees Gujarat to position its capability not just in drug manufacture but in production of related machines too said Desai.
Alvita Pharma has done fairly well in Gujarat, because the focus is mainly on exports. In order to maximize the advantages of this state, we are focusing on niche generic products and bringing in new formulation technology and work on NDDS(new drug delivery systems), where there are few players in this state. This would enable us to maximize our capability, said Vora.