synthesis and process engineering and developing, without compromising on quality, cost-effective technologies in the shortest possible time for drug intermediates and bulk activities. The Indian pharmaceutical industry has the highest number of plants approved by the US Food and Drug Administration (FDA) outside the US. It also has the largest number of Drug Master Files (DMFs) filed which gives it access to the high growth generic bulk drugs market. Generic drug manufacturing is the main growth driver for the future. India is set to capture a large portion of the market by leveraging its inherent strengths in technology, R&D facilities and trained human capital.
Ayurvedic medicines have become very popular in Latin America. Ayurvedic Spas are becoming fashionable in Latin America. Companies such as Dabur and Himalayas have already made entry. Given the Latin American regard for Indian Culture, spiritualism and yoga, there is very good potential to export Ayurvedic and natural products.
Latest trends -
New pharmaceutical regulations were enforced in 2005. By updating Article 376 of the General Health Law in January 2005, product registration is no longer unlimited. From now on, it will last for a five-year period. At the same time, bioequivalence standards are finally fully implemented. This means that copycat products are no longer exempt. Also, the drug classifications will be reduced to four categories.
As a result, the market is expected to shift. Bioequivalent generics, which represented around 2.7% of the pharmacy sector recently, are expected to increase their share in 2006, taking over most of the sector left by copycats, which accounted for 10.3% in 2003. For research-based products, the only competitors will be bioequivalent generics. There is a new wave of generic producers looking for business opportunities in Mexico.
Further regulation is also expected regarding over-the-counter (OTC) switching and advertising. OTC advertising was further regulated in 2005, which means that many 'miracle products' will be withdrawn from the market. Overall, the OTC sector will increase in 2006, fuelled by more consumer demand.