What is ailing Indian Pharma Industry

Due you know that Indian Pharma industry has more than 10% share in the global medicine production. The secret is R&D as well as cost effective generic medicines production. In the year 2012 out of the total production of US$ 22.6 billion, medicines worth US$ 14.84 billion were exported. USA is one of the major importer of our medicines.

But of late it appears that all is not well here in Indian Pharma. It was in September this year Usa drug regulator Food and Drug Administration has made surprise inspection of sun Pharma's Hallol Plant in Gujrat, on the basis of reports on violation of good manufacturing practices. 

Recently as many as 14 women were succumbed to medical misconduct in Bilaspur. As an aftermath, Rameshwar Mahawar of Mahawar Pharmaceuticalsand Rakesh Khareof Kavita Pharmaceuticals arrested, it was alleged that Ciprofloxacin manufactured in their units was laced with rat poison. In fact it is not first time for Mahawar, even in the year 2012 also, when they were stopped from manufacturing sub standard drugs for 90 days. The basis on which it was allowed to resume production after ban is not clear. Incident of this gravity needs lot many clarifications, on the first place who is responsible for public health? Is the role of the national regulator is limited to handing out punishment to those who indulge in fraud retroactively? Why do not our regulators work proactively like USFDA did  in September and thus prevent loss of human lives.

In 2012, a report was tabled in Parliament on the functioning of the Central Drugs Standards Control Organisation (CDSCO) which says inter alia  ' there is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDCSO and some medical experts.' The report also indicated serious shortcomings in Centre-State co-ordination in implementation of Drugs & Cosmetics Act and Rules. It also pointed out that age old rules for qualifications to head crucial authority like CDSCO. 

In last two years, CDCSO's budget increased, more resources allocated, coordination between the Central and State health regulators have been streamlined. But these perfunctory changes do not address the root cause of the problem.  It is not important how many inspectors are available

, what kind of budget it commands but in terms of it's core mission : how effectively and proactively our regulars work and protect public health.

When Dinesh Thakur a whistle blower raised a serious case against Ranbaxy in May 2013, CDSCO made public commitment to inspect the facilities that produced adulterated and substandard drugs for US Market. We are yet to hear the outcome of these inspections.

In the meantime, 15 other well known India based Pharma majors, whose medicines are used extensively in India have been cited by the USFDA for 'data integrity'. During the inspections FDA found that these companies were faking test results to make bad medicines good! Some of these facilities have been put on the import ban list..examples of the cited behaviour include releasing failings product, reprocessing failing products with different test parameters to make a past, backdating the test results, in fact there is an urgent need that CDCSO should immediately take up this role in case it is serious to save our Pharma Industry.