With the aim to step up pharmaceutical exports from Indian SME sector, the Pharmaceutical Export Promotion Council (Pharmexcil) has made some significant recommendations to the Union government. The suggestions if implemented can drastically change the image of Indian pharmaceutical products in the international market according to Ashutosh Gupta, COA member of Pharmexcil, who was here in Chennai recently to attend a seminar.
He said 'Brand India,' the export promotion initiative of the Union Commerce Ministry, will help the Small and Medium pharmaceutical units (SMEs) in the country to increase their exports and enhance the country’s image. But for the brand promotion, the small and medium units require more investments for the companies’ overall development. Big opportunities are waiting for the pharma sector in 2012 because of patents expiry.
According to him the Indian API units are gradually dying. There is a looming Chinese threat to the manufacturers of intermediates/API’s and formulations. China controls 60 per cent of the API market in the world, and sells the intermediates and the raw-materials at cheaper rates. This is causing serious concern for the API industry in India. He alleged that there was no support from Government or PSUs to the API industry. So, India is going to a state of over dependence on China.
He said only with some subsidy support, the API and intermediate plants can counter Chinese monopoly. Special incentive schemes should be given to these units so that they should not rely on China for their intermediates and in-turn they support and strengthen the Indian formulation industry. According to him, the SMEs are struggling for want of finance, and if they could be financially sustainable, they can easily comply with GMP and GLP standards. If so, the image of the Indian SMEs will improve and the brand building of Indian products will also become better. But these units require huge investments for their entry into regulated markets.
The Government may reimburse the units the expenses incurred on bio-equivalence studies, submission of DMF and ANDAs. The reimbursement should be minimum 50 per cent of the expenses and the charges can also be fixed by the government. Bio-equivalence studies are carried out to check the potency of the drugs in comparison with the brand leaders or innovators of the drug in the target country. It is carried out on patients normally 24 patients to check the effect of these drugs on them. Normally every country which has a regulated set-up wants these studies to be carried out in their approved centres. Therefore, the cost of these studies has increased and it costs around Rs. 50 lakhs to 2 crore per product depending upon the market.
“Today, India is recognized as the best source for low cost generics whereas Indian pharma industry has the huge potential for brand development. But we are not able to enter into brand development due to lack of finance and enterprise. Brand development has huge profits and also the quantum of exports multiply in the same volume. We are today recognized as just the contract manufacturers for the world, it has to be changed,” he told the exporters.
Subsidy for upgrading GLP should be provided and to compete internationally, the units must be given automation subsidy. They need incentive for entering into regulated markets. Marketing co-operative societies can be formed in other countries to promote brand development. Research centres like NIPER can be established to create trained personnel for these SMEs. According to him, it is clusters that will do good instead of SEZs. So, more clusters are needed in various parts of the country. All the schedule M units should be given subsidy for up gradation from schedule M to cGMP. Likewise, under focus market scheme, incentives should be given for bulk drug industries also.
He said a special diplomatic task force has to be created representing technical officials and guided by ministerial delegations to help upgrade the image of the Indian Pharmaceutical products abroad. Now a days, the international conditions are very volatile and the regulatory authorities are becoming more and more stricter. But there are global opportunities awaiting Indian products in the international markets. A fixed incentive should be given to exporters for entry into regulated markets like- USA, Europe, Russia, Brazil, and Colombia, which are dominated by big pharma companies. The SMEs are lacking trained and specialized manpower. Because of these factors, it is too difficult for the SME units to attain the confidence of government easily.
Regarding Indian Pharmacopoeia he said today Indian Pharmacopoeia is at par with British Pharmacopoeia. Cost effectiveness, better documentation and better product range are helpful for a better Pharmacopoeial leverage of Indian brand. India should be strong enough to compete with other countries in brand promotions, so that it can become at par with other countries. Through international participations, the country will get a better brand image and exposure that will increase the exports.
He suggested that there are well established Indians abroad and they should be enrolled as associate members for the brand promotion drive as they are highly potential and influential people. Their participation will provide vast scope for improvement. Embassies in important markets may be provided with a qualified technical person who can tackle technical issues sitting in that country, he said.
Ashutosh Gupta was giving a lecture on 'Brand India,' in a seminar organised by Pharmexcil in Chennai.