Metina Consultants has viewed the emerging markets of BRICS (Brazil Russia, India China, South Africa), Turkey, Mexico, Chile, Argentina as among the top ten emerging markets, despite competition for generics and slow and long-drawn approval process by regulatory authorities and government initiatives favouring local companies. Further many of these countries mandate paper based common technical document (CTD) submissions and site GMP inspection for specific therapeutic category.
Although the emerging markets are seen as prime revenue sources for pharma exports, there are insurmountable challenges posed by the governments and regulatory authorities in those countries. These include continuous change for improvement in guidelines, complicated regulatory process for dissolution, Good Manufacturing Practices (GMP).
These regions are among the leading destinations for the pharma products, said Hasumati Rahalkar, head, Metina Consultants at a DIA conclave.
The key purpose of consultants in the region is to assess and understand the regulatory landscape of BRICS markets. There is a great need to identify the market help pharma companies overcome the major challenges for registration of branded generics in these markets, he added while giving an overview of the regulatory landscape in each of these countries.
In Brazil, the Regulatory Agency ANVISA coordinates with National Sanitary Surveillance System, National programme on blood and blood related products, monitors drug and medical device prices, regulation, control and prevention of smoking, grants patents to National Institute of Industrial Property.
In Russia, Roszdravnadzor is the main regulatory agency under the Ministry of Healthcare and Social Development. It is responsible for marketing authorization process and determines eligibility for price reimbursement. The Russian legislations are more closely align with EU norms. It has mandated GMP standards for local manufacturers with a deadline of 2014. To strengthen domestic GMP inspections, Roszdravnadazor has singed memorandum of understanding with PIC/S (pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme), said Rahalkar.
Russian Government has approved the concept to Develop Russian Pharmaceutical Industry by 2020. Its expectations are to receive 50 per cent market share for locally produced pharmaceuticals and less margins of patented products prices. The local manufacturing in Russia has increased due to discriminatory policy between locally manufactured and imported pharmaceuticals. For instance Krka opened oral solid dosage facility, Stada acquired Serbia based Hemopharm, PolPharma acquired Akrikhin plant, Bioton established insulin development plant, Servier opened tablet manufacturing plant.
India is the fourth largest markets in Asia Pacific region after Japan, China and South Korea and accounts almost 10 per cent global production of drug on volume.
The People’s Republic of China has a vast potential healthcare market and the State Food and Drug Administration which is the main regulatory body poses lengthy approval process.
The Republic of South Africa is the largest drug market for Anti-retrovirals (ARVs) with well established local manufacturing and high disease burden. Its regulatory agency Medicines Control Council (MCC) under Department of Health poses new timelines for new chemical entities (NCE) within 12 months, generics within six months and clinical trials within 60 days.