Advertisement
Saturday, Oct 23, 2021
Outlook.com
Outlook.com

Big Pharma Firms Play Around Drug Norms And Prices, Launch New Medicines Without Approval

The pricing authority listed 201 formulations of different drugs manufactured by companies.

Big Pharma Firms Play Around Drug Norms And Prices, Launch New Medicines Without Approval
Big Pharma Firms Play Around Drug Norms And Prices, Launch New Medicines Without Approval
outlookindia.com
2017-05-18T14:15:00+05:30

The National pharmaceutical pricing authority has issued a notice to pharmaceutical companies for launching combination drugs without taking approval of the drug regulation authority and violating price norms.

The pricing authority listed 201 formulations of different drugs manufactured by companies, including GSK, Abbot, and Dr Reddy’s Labs, Lupin, Ranbaxy, Sanofi and others, who have fixed prices of new combination drugs launched in the market without complying with price control norms.

The Memorandum reads, “Companies have launched formulations by altering a scheduled formulation with strength dosage as specified under DPCO and/ or in combination with other non scheduled medicines without even applying for price approval from NPPA as required under para 15 (2) of DPCO 2015.

Under the Drug Price Control Order (DPCO), all new drugs launched in India need to apply for price approval and submit the formulation of drugs before being launched in the market.

The pricing authority has also raised issues on whether the drugs have been approved by the Central drugs standard control organisation, raising questions on whether they are rational or irrational drugs since most are fixed dose combinations.

NPPA, in the memorandum, have asked all companies mentioned to submit batch-wise production and sales details of the drugs. In addition, the companies have also been asked for maximum retail price of the drug from the date of launch of production. The companies need to submit all information till the 15th of June, non compliance of which will lead to action by the NPPA.

According to NPPA’s guidelines on overpricing of drugs, in case a company does not respond to a show-cause notice on the overcharging of a drug, the regulator shall fix the price of the medicine and calculate the overcharged amount based on the difference between its price and the maximum retail price. The company is also liable to pay a penalty, not less than 100% of the principal amount.

Advertisement

Outlook Newsletters

Advertisement
Advertisement
Advertisement

Read More from Outlook

Global Hunger Index Might Not Be Flawless But India Still Needs To Take It As Warning

Global Hunger Index Might Not Be Flawless But India Still Needs To Take It As Warning

The Centre has reacted angrily at the new Global Hunger Index, but experts say it should plug loopholes in the food delivery system.

Didi's 2-Day Goa Trip Not A 'Vacation' As TMC Pitches For 'Gonychi Navi Sakal'

Didi's 2-Day Goa Trip Not A 'Vacation' As TMC Pitches For 'Gonychi Navi Sakal'

West Bengal Chief Minister Mamata Banerjee's visit comes as the TMC appoints former Goa chief minister Luizinho Faleiro as a national vice president.

No Pressure From BCCI: Ganguly On Kohli's Resignation

No Pressure From BCCI: Ganguly On Kohli's Resignation

Ganguly said that Kohli's decision to step down from T20 captaincy after the World Cup was his 'own decision'.

100 Crore Shots: How Modi Govt Scored Its Vaccination Goal In 280 Days

100 Crore Shots: How Modi Govt Scored Its Vaccination Goal In 280 Days

Prime Minister Narendra Modi described the feat as 'a journey from anxiety to assurance' that has made India stronger.

Advertisement