Despite Mexico being a potential market, Indian pharmaceutical companies are finding it difficult to enter that market mainly on account of its stringent drug registration and other regulatory procedures. The visiting Mexican delegation of pharmaceutical companies and regulatory officials are also not able to provide any hope of an improvement to this regulatory tangle in that country.
A team of 10-12 members of Mexican pharmaceutical industry and regulatory authorities are on a visit to India from this week. The team has a schedule of meetings from March 7 to 14. The team will be visiting the facilities of Strides Arcolab, Biocon, Shantha Biotech, Aurobindo Pharma, Centre for Cellular and Molecular Biology, Cipla, Wockhardt, Sun Pharma, Nicholas Piramal, Ranbaxy Labs and Dabur. The team will also be meeting with officials in the health and commerce ministries.
Mexico is one of the large pharmaceutical markets in America with a size of over $ 10 billion, a market bigger than Brazil. Not many Indian pharmaceutical companies have been able to tap this market unlike Brazil.
Major reason for this inability is the stringent regulatory requirements of Cofepris, Mexican authority and an equally unfriendly attitude towards generics from Mexico.
As per Cofepris statutes, a foreign company will have to tie up with a local company or have its own independent manufacturing facility in Mexico if it wants to export to that country. Moreover, it takes a lot of time for product registration in Mexico. Also, according to Indian industry officials, a lack of comprehensive generics policy in Mexico clearly shows the influence of US in its policy-making initiatives.
The reason Indian companies were able to flock to Brazil was due to ANVISA's easy and speedy approval process, whereby a foreign company could export to Brazil without much hassles. Moreover, there was a separate fast track system for a speedy registration process.
"Indian companies are following a wait and watch policy. Mexico will have to evolve a comprehensive policy on generics. India can offer Mexico with high quality generics in a cost effective manner," said Ajay Piramal, chairman, Nicholas Piramal India Ltd.
"Mexico is a lucrative market and Indian companies would like to enter the market. However, the authorities have to show more acceptance for generics, make arrangements for speedy clearance. An Indian company would invest in the country only when it get better returns on the time and the resources it has invested for the market," said Dr. PA Mody, chairman Unichem Labs.
Mexican authorities also seemed to be apprehensive about the hygiene and sanitary conditions in Indian pharmaceutical factories. "If India is capable of exporting high quality products to a more advanced market like US, why then Mexicans are worried about our sanitary standards," queried an industry official.
There are about 200 pharma companies in Mexico, of which 38 are API manufacturers. The market is growing at a rate of 10-11 per cent annually. Out of the total produce, about 60 per cent is bought by the government institutions, which contributes to 20 per cent of the total value of sales. The rest is sold on private basis, forming 80 per cent by value of sales.
There are about 23,000 pharmacies in Mexico. MNCs are among top 10 pharma companies in Mexico, led by Pfizer. MNCs contribute 50 per cent of the total sales of the market.