New Delhi: India’s pharmaceutical industry regulator will scrutinize all drug applications and dossiers filed by Ranbaxy Laboratories Ltd, as well as court documents presented in the US, to find out if there have been any breaches of the Drugs and Cosmetics (D&C) Act, said drug controller general of Indian G.N Singh in an interview. The action comes after Ranbaxy on 13 May agreed to pay $500 million to settle civil and criminal charges of making fraudulent statements to the US Food and Drug Administration and selling adulterated drugs. “No one and no company is above rules,” said Singh. Edited excerpts:
What is your biggest concern in this case?
Strict enforcement of the D&C Act is my main concern. This remains my biggest challenge. We want companies operating in India to follow established procedures and will initiate necessary steps to ensure that. No one and no company is above rules.
What sort of action is being initiated against the company?
Under the Drugs and Cosmetics Act, we will take action against the erring company. We will have to look into the facts and documents in the coming weeks.
Does it concern you that the Ranbaxy verdict may harm the generic drugs industry?
No. These are different matters altogether. Besides, my primary concern is not the growth of the industry, but the safety of patients. I want to assure people that the drugs currently allowed in the domestic market are of good quality and as per the D&C Act. We have no reason to believe that the company has violated Indian laws. The matter, however, is currently being looked at.
What have the health ministry’s directives been with regard to Ranbaxy?
This is a part of routine procedure. Our job is to keep a close watch on the companies, and we will do the needful in this case. We will be combing through the court documents. My job is to ensure 1.2 billion Indians have access to safe and efficacious drugs. One must understand that the law of the land is different in United States, Japan and India. The same applies to drug regulation. We export drugs to 218 countries, and we are conscious of our responsibility towards health of all those who use Indian drugs. From time to time, we have put companies on alert and taken appropriate action against then when violations have been established.