Karnataka-based active pharma ingredients (API) and formulation company, Bal Pharma is working to strengthen its presence in the Commonwealth of Independent States (CIS) region. The company which has registered its antibiotics drugs in Russia and Uzbekistan is now looking to expand its portfolio with anti-diabetic formulations.
“We are looking to increase our products in the CIS which is an important market in our global strategy,” said Archana Mitra Dubey, associate vice president, exports, Bal Pharma Limited.
Going by the growth potential in the lifestyle and infectious diseases sector in CIS, we have identified drugs in the anti-diabetic and antibiotics range which are under registration in Belarus and Ukraine, she added.
The company sees CIS as an indispensable area of growth opportunities. The market is largely made of generics. Disease patterns are similar like India with diabetes, cardiovascular, respiratory and dermatology disorders on the rise.
In April this year, a new set of regulations have been introduced making the market more defined. There are stringent laws in place to market a drug. These include a specified period of 210 days for registration processes and a fee of $10,200 or Roubles 300,000 for new drugs to be registered. CIS has also mandated the need to conduct clinical trials for new drugs prior to its registration. A clinical trial conducted on an international basis will be acceptable if it included Russian patients.
Bal Pharma like any other Indian pharma company in the region is trying to make the best of new opportunity. So far Indian companies are getting away selling old molecules but now with the new regulations novel drug brands will dominate the portfolio of products. “We need to pick and choose our offering to CIS which could slow down our entry into the region. However, going by the scene in the regulated markets, which does not seem to be rosy, CIS holds more promise and is posing to be a lucrative proposition despite the stringent norms. The competition is not unmanageable here and that is a key attraction in this market,” said Mitra.
Commenting on the new regulations imposed by CIS, she said that entering the market is itself an expensive proposition. To survive in this market mid-sized players will find it tough. On the one hand, quality standards of drugs being monitored through clinical trials along with dossier submissions and on the other it is high cost of product registration. These factors are challenging for small and medium sized companies which re-organize their product basket to maximize revenues from the region, stated Mitra.