The India pharmaceutical industry is incredible in more ways than one. On the one hand, it takes pride in the fact that India is home to the largest number of drug-making facilities outside the US that are approved by the US Food and Drug Administration (USFDA) - over 600 of them. And in the fact that Indian companies lead in the number of applications for generic drug approvals - Abbreviated New Drug Applications (ANDAs) - in the US. About 40 per cent of the generics supplied to the US, by volume, come from India. On the other hand, the number of Indian companies getting pulled up by the USFDA for non-compliance with good manufacturing practices is rising. One reason is the increasing dominance of Indian companies. India and China lead in the number of warning letters issued, outside the US, by the USFDA.
"Do not go back with the feeling that we are seeing more warning letters because there are more inspections. There are concerns too, and recurring citations that companies need to look into and address," an official from a global regulatory agency cautioned an official of an Indian company. The person mentioned this at a four-city advanced GMP (good manufacturing practice) workshop that global regulators USFDA, MHRA (Medicines and Healthcare Products Regulatory Agency, UK) and EMA (European Medicines Agency) conducted in India recently.
Analysing its findings in India between 2013 and 2016, an official from the EMA, responsible for evaluation, supervision and safety monitoring of medicines in the European Union, put up non-compliance issues into 10 categories ranging from data integrity, documentation and records, contamination and quality control to those around manufacturing and personnel training. Those from the USFDA also made some hard-hitting observations.
But then, regulatory challenges are just one set of problems. The companies are trying to cope with issues ranging from price erosion in the US to regulatory changes and uncertainties at home. As this package on pharmaceutical and health care shows, the sector is hurting from a combination of factors that have come together like never before. The report by P.B Jayakumar takes you through the minefield faced by Indian companies in global markets, mainly the US. This is followed by a report on options the companies are left with on the home turf and the likely new growth drivers such as products with limited competition and a portfolio in biosimilars that most companies are building. Joe C. Mathew takes a look at India's moves against import of bulk drugs from China that was threatening to eat into Indian players' pie. In health care, Gina Krishnan looks at new hospital chains coming up in Tier-II and Tier-III towns. Finally, Rana Mehta, partner, Healthcare, PricewaterhouseCoopers, takes a journey into how technological changes are transforming the face of pharmaceutical and health care industry.