Pharmaceutical exports from West Bengal and other north eastern states have not been growing for last many years despite the region having 164 medium and small scale pharmaceutical units. Most of these units are manufacturing drugs for the domestic market especially for the north eastern markets.
Lack of awareness about drug export regulations and inadequate financial support from public sector banks are cited as two key reasons why the pharma SMEs in West Bengal and north-eastern states were unable to venture into overseas markets. Export of pharmaceuticals from north eastern states currently is less than Rs.50 crore.
The Union commerce ministry has decided to bring the drug units from these areas into export sector and make them aware of various incentive schemes offered by the ministry. For this it has started organising a series of seminars and workshops for the benefit of manufacturers.
As a part of this initiative, the Pharmaceutical Export Promotion Council (Pharmexcil) organised a seminar-cum-interactive session in Kolkata on June 3 for small and medium scale pharma units of West Bengal. According to sources from Pharmexcil, the commerce ministry wants to bring a brand image for the Indian products in overseas markets, besides aiming to enhance pharma exports.
Dr Somani said that SMEs in West Bengal, particularly in the north east, can take up export business if they understand and comply with the regulations. Lack of clear understanding about the regulations is the main reason for the north-east manufacturers in not venturing into overseas marketing, said Dr V G Somani, deputy director, CDSCO, Kolkata.
While delivering the keynote address in the seminar, Dr Somani said there exists a lot of potential for SMEs in West Bengal and the government wants to give them many exemptions. If the manufacturers are able to comply with the regulations of other countries, they can register their products in those countries and engage in overseas marketing in regulated and non-regulated markets.
For promotion of exports the leaders of the eastern pharmaceutical industry should study all the relevant regulations of the countries to which they want to export. It is also essential for them to understand the need of each targeting country, so, the export will become easy. He advised them to keep in mind the fact that quality is the prime factor for every product. Like in other parts of the country, in West Bengal too, the industry has strength, technical manpower, machinery and quality of the products are good. But the manufacturers are not willingly come forward to do export business.
He said there are certain international guidelines for overseas business and those who follow them will get certificates from National GLP Authority. Dr Somani reminded the aspirant-exporters should not to ask for dilution of regulations, instead, should strive to adhere to the regulations.
Regarding Good Laboratory Practices and submission of CTD, he said there are four aspects to be taken note of. They are general regulations, guidelines, formats (how to submit registration) and practices (on GMP, GLP and GDP).
He told the manufacturers that GMP did not mean merely the structural changes like modernized building which contributed only 10 per cent of the total assessment. The ninety percent is with regard to the scientific procedures of the production processes and the quality control system. Accurate results are expected from the laboratory practices. The pre-clinical toxicological studies (on animals) have special significance as they are preferred by international markets.
According to Dr Chintamoni Ghosh, the Director of Drugs Control, West Bengal, India can export its generic products to Japan as the country wishes to buy them from India. The only condition is that the exporters have to comply with the norms of that country as it is a regulated market. He said in the global market, Indian products have good reputation.
Dr C Ghosh wanted Pharmexcil to assist and educate the pharma manufacturers of West Bengal to do exports and let them know about the incentive schemes implemented by the government.
Later while speaking to Pharmabiz, the executive director of Pharmexcil, Dr P V Appaji said that the Council organised the meeting for the small and medium scale pharma manufacturers of West Bengal to promote pharma exports from Kolkata and from neighbouring states. He said there is scope for pharma export through Kolkata airport and sea port.
COA members of Pharmexcil, Abhay Kumar Sinha, Ashuthosh Gupta, Bhavin Mehta and ADC-CDSCO, Rubina Bose have also shared the dais with the speakers.