Implementing norms similar to that of European Union, the Russian health ministry introduced stringent norms for drug marketers from January this year.
MUMBAI: Domestic pharma firms are bracing to unleash purse strings in a bid to comply with the new norms set by the Russian Federation, a market worth $9 billion at the consumer level growing at the rate of 10-12%. Implementing norms similar to that of European Union, the Russian health ministry introduced stringent norms for drug marketers from January this year.
India has a share of 8% as supplier in Russia, supplying drugs worth Rs 572 crore during the period of April 2006-October 2006 period, against Rs 560 crore for the corresponding period the previous year. Around 15-20% extra money will have to be shelled out to comply with the norms. But these new norms are said to be a major setback to the small scale companies, who supplying the drugs there through distributors.
The ministry has insisted the companies to submit data on various phases of pre-clinical as well as clinical trials of the innovative drugs.
“The submission of clinical trial data will be easy for the bigger drug firms. But for us, it will be a difficult task,” an official with a small scale company said. The ministry is learnt to have also insisted to submit all documents related to the marketing of the drugs in Russian language, along with an English copy.
Earlier, only the basic information on the drugs and its efficacy were to be submitted in Russian language. All other details were to be given in English.
Registering one foreign drug for 5 years in Russia costs around $12,000, while domestically made drug costs $6,000. The certification system, which came into effect in December 2002, required for each and every batch of medicines entering the market, costs 2,000 roubles for domestic companies and 3,000 for foreign companies.
BS Avari, vice president, International Division, JB Chemicals & pharmaceuticals, said, “We expect around 20% more cost from the present expenses to comply with the norms.” JB Chemicals has been marketing around 50 products in Russia, where the company recorded around $49 million sales last year 2005-2006.
“The implementation of the norms insisting on different languages on each parts of CIS countries also cost us more,” Avari said.
According to the norms, the application must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product, including bioavailability of the drug product.
Apart from JB Chemicals, Ranbaxy, Lupin, Lyka Labs, IPCA Labs have also good presence in Russia. “We have only to do the submission of the details of validation of analytical method as per the new norms. As we have already the required data, we do not want to cough up extra money to make us compliant,” a senior official, who handles IPCA’s foreign operations, said. IPCA Labs has recorded sales of $30 million in Russia last year.
A Lupin spokesperson said, “The Russian FDA is in the transition phase. Lupin is well versed in dealing with advanced market FDA’s like US and Europe, it is well positioned to deal with the regulatory requirements of Russian FDA. There would not be a significant impact on the existing and intended business.”
Lupin has around 10 products registered in Russia and around 5 in pipeline.
Ranbaxy registered sales in Russia including Ukraine belt of $ 65 million in 2006. It is among the top 10 foreign generic companies in Russia.
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