Tamil Nadu pharma industry is a fast growing sector and the state is becoming a promising destination for pharmaceutical and cosmetic products. A significant portion of the medicines exported to different countries such as US, UK and African continent is from Tamil Nadu. The first Pharma Estate, approved by the Central government in the early 1980s to promote the pharma sector, was set up in Tamil Nadu only. The state has the presence of manufacturing facilities of several MNCs, big players influencing the domestic market and more than 400 manufacturing companies are coming under the SME sector. The pharma sector in the state has also produced leading industry captains in the national level. J. Jayaseelan, Chairman of the Tamil Nadu IDMA and Secretary of IPA state branch, speaks to Peethaambaran Kunnathoor, the Chennai correspondent of Pharmabiz, about the current position of the pharma industry in Tamil Nadu state.

You are a successful pharmaceutical entrepreneur and a spokesperson of the Tamil Nadu pharma industry as well as pharmacy profession. How do you rate the pharma industry in Tamil Nadu with those of other states, especially of Gujarat and Maharashtra? What is the future of TN pharmaceutical industry?
In total, the Tamil Nadu pharma industry needs more support from the Central and state governments. The state has the highest number of small pharma entrepreneurs in the country. Many professionals started their own marketing companies and doing well. If the industry gets conducive atmosphere for growth, all the units will have better future.

As the secretary of TN IPA and chairman of IDMA Tamil Nadu State Board, you are always involved in organisational activities. Could you give a brief description about the pharma industry in the state with classification on strength of the units? How many units in total, how many MNCs or major players? Number of SSI units?
The first pharma park of the country was established in Chennai during the regime of late Dr. MGR as chief minister. Unfortunately that was the last pharma park. The first medical equipment park also came  in Tamil Nadu. In the area of medical tourism, Tamil Nadu is the leading state in the country. There is an exclusive biotechnology policy, but no pharma policy. For some reason, the focus on pharma industry is not adequate in the state when compared with other states like Gujarat or Telengana. However, the entrepreneurs in Tami Nadu have risen to the occasions and set up their pharma companies successfully.

There are around 10 US FDA approved, 10 UKMHRA approved and over 300 WHO GMP approved manufacturing facilities in Tamil Nadu.

There is complaint from the SME sector that government policies are always becoming detrimental to the growth of small scale units. Many small and medium pharma units are closing down due to unfavourable rules and regulations. What has been the situation hitherto in Tamil Nadu and what is at present? How does the state government help the pharma industry?
Most of the small scale units in the state are contract manufacturing companies. Because of the strict Schedule M implementation, many small companies have vanished from the scene. They could not invest in much and upgrade their facilities. But, there are over 1500 pharma marketing companies in Tamil Nadu and the number will be the highest in the country. Their strength is in the SME sector. These companies need significant support for their growth. Special attention should be given to pharma sector by government and I think there is no hurdle from the state government.

There are so many challenges faced by the entrepreneurs in pharma sector in terms of infrastructure facilities, access to raw materials, skilled workforce, marketing of products…etc.  In the organisational level how can their grievances be resolved?
IDMA is representing the grievances of the manufacturers regularly and if needed IDMA takes legal action too. Regarding raw materials we have the capability to produce any raw material, but due to NPPA restrictions we are forced to buy raw materials from China. They are able to give on moderate price because of their reduced manufacturing cost. API being cost sensitive sector government support to API industries can bring down the cost of production in India also.

You have come up in the backdrop of Tamil Nadu pharma industry and you belong to the state itself. You may be aware of the sequential development of the Industry here.  What is TN IDMA’s initiative to save the SME sector which is considered as the vehicle of growth?
IDMA intervention in fixed dose controversy, FSSAI issue….etc helped small industries straight away. The involvement of the IDMA state branch in the Pondicherry issue helped the SME units there.  In Tamil Nadu, there is no deficiency of talent pool. We have enough qualified pharmacists and other pharma related personnel in the state. New entrepreneurial development is happening in pharma marketing. However we need to go a long way for improving our manufacturing sector both in formulation and API.

Several of the SSI units are engaged in contract manufacturing for their survival. According to you, what step the government should take to prop up the pharma sector. Has your organisation submitted any proposal to the government in this regard?
IDMA submitted proposal for separate pharma policy for the state which is still pending. Currently there is only biotechnology policy. IDMA requested for bulk drug park for which the state government has allotted around 800 acres and the proposal is still pending with the central government. We are requesting the state government to give preference to Tamil Nadu manufacturing companies for purchasing medicines through TNMSC. If this happens, lot of companies  in the state can grow.

The pharma industry associations like IPA, TN IDMA and PMA Tamil Nadu have initiated steps for setting up a Pharma Cluster in Chennai with the help of state government and central government. There was also one proposal for a second cluster to be set up in Madurai. What happened to the proposals or what is the bottleneck to accomplish at least one project?
The first cluster at Alathur got approved already and work is progressing. Madurai Cluster will be late. We are expecting bulk drug park in Chennai which is pending with the central government.

Apart from a resourceful industry association leader, you are the MD of Delvin Pharmaceuticals, Chennai. As per available statistical report, there are more than 400 SME units operating in Tamil Nadu. Do you think that Tamil Nadu is a promising destination for pharma industry, if not, what are the hiccups?
Tamil Nadu has enough educational and financial resources and political stability. We have enough skilled and semi skilled people. So the state is very ideal for pharma business. If a small push given by the government with incentives, the state can become better destination for pharma.

In your perspective what strategy is fundamental for the overall growth of SSI pharma sector and to enable the units to find a space in export market as well as in the domestic market?
The promoters should get prepared for stringent regulations and they need to get updated on international pharma regulations. This can help them to explore and excel in exports. Banking support with interest concessions will help the SMEs.

On regulatory side, how do you view the enforcement activities of the state drugs control department and what more, in your opinion, steps needed to be taken? Similarly, how far the services of the office of the CDSCO South Zone are helpful for overseas business?
The state drug control department and the CDSCO are doing good job. They are enforcing the required laws and taking measures, and at the same time helping the industry to grow in positive directions. Both the departments help for the export growth in the state.

Coming to the professional side of pharmacists, how does the pharmacy education support the areas of formulation development, distribution and patient care in Tamil Nadu?
Regarding pharmacy education the government should start pharmacy colleges in all the medical colleges of the state. They also should start Pharm D course in the government institutions. Soon we need to make the minimum qualification of a pharmacist in the retail pharmacy as B Pharm instead of D Pharm. If we want to be a developed country then we need to follow the process happening in developed countries. Institution and industry relation can improve the R&D focus.

For the employment generation of pharmacy graduates, what idea you have in mind? Is Tamil Nadu pharma industry a promising area for the upcoming pharmacists?
If we make the minimum qualification of retail pharmacy as B Pharm, it will create immense opportunities for their jobs. Currently the pharmacy graduates are getting good jobs and the industry needs more pharmacists. There is no problem for getting good placements.

You are the secretary of TN IPA and also a member of the state Pharmacy Council. Can you please recount the contributions of pharmacy educational institutions in Tamil Nadu? I mean the colleges in the private sector?
In Tamil Nadu the contribution of the private pharmacy colleges is noteworthy. Fifty years before, we had only two government colleges to conduct pharmacy degree courses.  For some reason neither the government increased the number of seats in these neither colleges nor started new colleges. This gap was addressed by private colleges only. If private colleges are not there, the industry will suffer very much to run their business due to lack of pharmacy graduates.

The ISM manufacturing companies in Tamil Nadu are also members of IDMA state unit. They are facing serious problems with regard to regulatory matters. As far as Tamil Nadu is concerned, it is the hub of siddha system and there are more than 600 companies engaged in the production of Siddha medicine. Does your association have any idea to save the ISM industry in the state to promote the traditional medicine market?
IDMA initiated lot of measures to support these traditional industries. However, now separate regulations and regulatory bodies have come up. Separate associations are also there and they are approaching the government for getting support. Where ever help is required, IDMA is playing its role perfectly.

Please give a brief about your company and product profiles? How many international markets have the footprints of your company?
I am a pharmacist from MMC and I am one of the first generation entrepreneurs. Having worked in marketing in various companies like Torrent, Eli Lilly, Sun pharma and RPG life science, I started a marketing company initially. Later joined with Samyshanmugam, a scientist in USA and promoted one formulation unit, one API plant and one CRO. We got US FDA approval for all the three units and later sold all the three businesses to PAR Pharma USA for a total value of over 70 million USD.
Currently, we are running Nuray Chemicals Pvt Ltd (US FDA approved API facility), Saimirra Innopharm Pvt Ltd (PIC's approved formulation facility), Delvin Formulations Pvt Ltd (Pan India marketing company), Delvin Surgicals (marketing surgical) and Delvin Klarvoyant (marketing medical devices).

You are the co-chairman of the organizing committee for the IPC 2016. According to you, how will this IPC be different from the past ones? How do you assess the relevance of the theme this year?
As Co-Chairman of IPC, I am focusing on the pharma expo in the event. This IPC will have more relevant topic for the lectures and symposiums. ‘Quality pharmaceuticals and patient welfare’ is the theme. This is apt in current scenario. Medicines cannot be sold but has to be dispensed. The theme focuses on the patient welfare which is very significant.