The Ranbaxy episode in perspective

D. G. Shah | Updated on November 23, 2017 Published on October 03, 2013


Drug companies the world over have been pulled up, but Ranbaxy has raised awareness of the danger of non-compliance.

It would be incorrect to say that the domestic industry woke up to the stringent regulatory requirements of the USFDA only after Ranbaxy’s FDA experience. Those who ventured to the US market knew of the scope and mode of FDA inspections and audit.

The only difference the Ranbaxy episode made was on two counts: first, they learnt of the risk and rigours of non-compliance; and second, they realised how severely their valuations could be hit, if they had significant exposure to the US market.

It was also known that the pharmaceutical industry is facing increased scrutiny by drug regulatory authorities across the world.

The adoption of progressively higher standards of product safety and quality had led to a greater focus on data integrity and cGMP (current good manufacturing practices) compliance. However, lack of awareness and inadequate appreciation of these continually evolving standards could have resulted in some companies failing to meet the FDA requirements.

Useful insights

An analysis of warning letters issued over the last 42-month period (January 2010 to June 2013) by the Office of Manufacturing and Product Quality provides some useful insights into the changing profile of regulatory inspection and oversight.

Out of 67 warning letters, two-thirds were related to formulation facilities and only one-third were for Active Pharmaceutical Ingredient (API) productions plants. Thus, the greater focus has been on formulations.

A further analysis of this data shows that in all, 66 companies received warning letters during the 42-month period. One company, Apotex, received two warning letters. Prominent among those receiving the warning letters are Boehringer Ingelheim, Hospira, Merck KGaA, Novartis, Novo Nordisk, Sanofi Aventis, SmithKline Beecham, Teva and Wyeth Lederle.

It is thus obvious that both innovator and generic companies alike from all geographies have been receiving warning letters. Indian companies, which account for 40 per cent of DMFs to date and 37 per cent of ANDAs in 2012, accounted for only 12 per cent of the warning letters.

An analysis of 178 incidences of drug recalls, market withdrawals and safety alerts by company during the period under study is presented in the table. A hundred and twenty companies contributed to 178 incidents. Ninety six of these companies had just one drug recall, market withdrawal or safety alert.

The remaining 24 were caught more than once. These include three local American companies: American Regent (13 instances), Hospira (10) and Bedford (6).Three major Indian companies, Glenmark, Sun and Ranbaxy, were among companies that had one violation each.

Change called for

Well-recognised companies including Apotex, Bausch & Lomb, Bayer, BMS, Cephalon, Genentech, Gilead, GSK, Greenstone, J&J, Mylan, Sandoz, Smith & Nephew, Teva, Watson and West Coast, have all been cited by the FDA. Again, this list indicates that both innovator and generic companies from all geographies have been found to be at the receiving end of the FDA.

The growing trend towards zero tolerance will necessitate changes in attitude and culture across an organisation. The Indian companies, to maintain their pre-eminent position, need to introspect and look for ways to overcome these challenges.

So what’s the solution? Can independent auditors resolve all these issues? The answer is ‘No’. Independent auditors can only expose technical deficiencies and help overcome them every time they find them. The solution will have to come from within the company, through a change in culture and attitude.

The regulator will play a role through its willingness to share responsibility with the companies for issues such as cGMP-related failures, and the implementation of processes that could address causative issues. Rather than just policing the industry, the regulator will need to consider itself partly accountable for failures, and shift its role from one of purely inspection, to one of training and capacity building.

(The author is Secretary-General, Indian Pharmaceutical Alliance.)

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Published on October 03, 2013
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