USFDA-hit Indian pharma looks for whistleblowers

Dec 14 2013, 08:55 IST
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SummaryIndian laws do not make it binding for a company adopt whistleblower policy.

Gurgaon-based Ranbaxy Laboratories troubles began when Dinesh Thakur, who had served on the board of the drug firm between 2003 and 2005, approached the US Food and Drug Administration and department of justice with proof that the company had indulged in data tampering, supply of falsified data to the regulator and production and sale of substandard drugs. It now turns out that one reason why Thakur chose to invoke the US robust whistleblower policy (which forced Ranbaxy to cough up $500 million) rather than first take up the matter with the companys top management was that the company then lacked a whistleblower policy.

Clause 49 of the listing agreement with the Securities and Exchange Board of India (Sebi) mandates disclosure of whether an entity has a whistleblower policy or not. However, Indian laws do not make it binding for a company adopt such a policy.

While some Indian pharma companies have adopted whistleblower policies, others, including some top-notch firms, havent. Lupin, Dr Reddys Laboratories, Wockhardt and Piramal Enterprises have defined their whistleblower policies, according to responses received from the companies to FE queries and disclosures in their annual reports. Lupin and Dr Reddys have even constituted an internal mechanism to handle such complaints.

A Lupin spokesperson said: Our top management itself is responsible for (the policy) and any such incidents get reported directly to an email box called A copy of the mails go to the vice-chairman, managing director and CFO of the company, so people have access to the very top tiers of the company (and) if they want to talk about anything they can do so fearlessly.

Dr Reddys said: We have a robust whistleblower policy. The chief ombudsperson is internal. Mumbai-based Sun Pharmaceuticals, Indias largest pharmaceutical company by revenue, said it is in the process of implementing a whistleblower policy.

With Indian pharma and biotechnology companies competing on a global platform, having whistleblower policies would enable them to try and resolve employee grievances within the internal framework of the company, without causing them to precipitate in the open.

Anand Mehta, partner, Khaitan & Co, said the amended Companies Act, 2013, has a new construct called vigil mechanism which makes it mandatory for a certain class of companies to have adequate safety measure to prevent victimisation of those employees who have blown the whistle.

However, the relevant rules have to be notified for this provision to be in force.

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