NEW DELHI: Many big drugmakers have come under the scanner of India’s drug pricing watchdog for excluding products from the price control regime without first applying for such an exemption, according to documents that ET has seen and people with knowledge of the matter. This is in violation of the Drug Price Control Order (DPCO).
The National Pharmaceutical Pricing Authority (NPPA) has found that companies launched products bypassing the regulatory framework.
The NPPA noted that some drug companies had launched anti-diabetes drugs under para 32 of the DPCO, without submitting the requisite application. This allows the NPPA to exempt certain classes of drugs from price control for a period of five years. It says that the price cap won’t apply if a new drug is developed through a unique and indigenous process, is patented under the Indian Patents Act and is not produced elsewhere.
Taking strong objection to “self-invoking” of para 32 of DPCO 2013, the authority called for action against “wilful defaulters,” according to the minutes of a meeting held on December 9 that ET has seen.
Companies Asked to Provide Data
“Self-invoking of para 32 of DPCO 2013 would tantamount to bypassing the regulatory framework and lead to chaos in product pricing, grievously impacting choices before the hapless consumers,” said the NPPA minutes. “Such attempts need to be checked forcefully in order to safeguard public health and safety.”
To explore details about DPCO