To build data bank, Centre asks pharma cos for details
New Delhi: In a major regulatory move to collect data about the Rs 1lakh crore drug market in India, the health ministry has made it mandatory for companies to disclose detailed information about their operations, products, production and sales among other things.
In a gazette notification published this week, the government said pharmaceutical companies will have to submit these details to the Drugs Controller General of India in three months. The health ministry has proposed changes to the Drugs and Cosmetics Rules, 1945 to make this provision mandatory, an official said.
“Any non-compliance to this rule will be treated as violation of the Drugs and Cosmetics Act and will attract penal action,” the official told TOI. The move assumes significance as the Indian drug market is highly fragmented and there is a dearth of data. While industry executives roughly estimate around 6000-8000 facilities including small, big and medium size players operating in the country, there are no figures available for products.
In the absence of any authentic data, the government often fails to monitor compliance and enforce law and many unapproved products continue to throng the market. The data received from companies will act as reference point for drug inspectors and state regulatory authorities who can use it for inspections, audits and granting approvals.