Metina PharmConsulting Private Ltd is looking to expand its presence in the South American region. The company which is already working in the region has seen growth opportunities for consulting.

In fact  the  emerging markets  of Brazil Russia, India China, South Africa (BRICS), Turkey, Mexico, Chile, Argentina are the promising destinations of the future,  Hasumati Rahalkar, Founder & Director, Metina PharmConsulting Private Ltd  told Pharmabiz.

This market offers opportunities in various business segments such as hospital products and differentiated products targeting life style diseases such as diabetes, heart diseases, obesity etc. Furthermore, diseases like cancer are on the rise, making it a market with huge demand for Oncology products, in which several Indian companies have renowned expertise, she added.

Indian companies offer generic/branded generic products at competitive costs, have excellent manufacturing & clinical facilities, follow stringent regulatory norms and have a vast pool of highly qualified scientists. Indian companies are also highly cost competitive in API’s. These factors make Indian companies ably suited to optimize the vast opportunities offered by the South American nations.

Although a few Indian pharmaceutical companies are facing queries pertaining to GMP standards from international regulators, this will have negligent impact on the overall Indian presence in Latin America, due to independent GMP evaluation by some of the leading regulatory authorities from this region, said the Metina chief.

There are three visible trends in South America for pharmaceuticals, said Rahalkar:

First is the  manufacturing capacities of domestic companies in Brazil, Mexico, Argentina and Columbia have increased substantially in the recent past. This makes such companies dominant in domestic tenders as well as private business.

Second the evolution of regulatory guidelines matching the requirements of highly regulated markets. This makes the role of regulatory affairs professionals very critical for penetrating these countries.

Third, until recently, most of the South American pharmaceuticals companies used to import finished pharmaceutical goods. With increased manufacturing capacities and better technology, we are seeing a rise in import of API’s which are then formulated locally.

The major challenge for entering South American markets is the lack of harmonization of regulatory requirements. Each country follows its own regulatory requirements for product registration in their respective national formats. Each of them have varied time frames for approvals, ranging from six   to 24 months.

The major challenge for Brazil is to manage regulatory process in orderly manner i.e. GMP Certification from ANVISA authority, Pharmaco-equivalence (PE) study, comparative dissolution study at REBLAS and Bio-equivalence study etc. The administrative requirements for CTD dossiers PERU becomes challenging for companies. In addition to above, the requirement of local BE studies and expectation of products manufactured at US/EU GMP approved facility restricts the scope of new product for Mexico. To get on time regulatory advice for clinical development of new product in itself is a real challenge for the companies, said Rahalkar.

Further, approvals in other countries are easier to get in comparison to Brazil, Mexico, Argentina and Columbia, which are the most stringent.  In terms of trade, Argentina follows stricter norms for import and has little import from India due to lack of Most Preferred Nation award. The routine challenges faced across Indian pharmaceutical industry are longer payment cycle and logistic issues i.e. cost of transportation by air shipment.

Apart from the above challenges, several South American markets are easy to penetrate and have huge demand for products in which the core strength of Indian companies lies, pointed out Rahalkar.