Karnataka DC dept intensifies its inspections on cardiac stent & medical devices; seizes Rs.66 lakh worth supplies
The Karnataka drugs control department is now closely investigating the stent pricing violation indicated by the National Pharmaceutical Pricing Authority (NPPA) against the Bengaluru-based Philomena Hospital and Cauvery Hospital in Mysuru.
With regard to medical devices, the department’s State Intelligence Bureau led by KS Nagajyothi, assistant drugs controller along with two drug inspectors - Shyamala J and Savitha BN - seized two medical devices - endo tracheal tubes and tracheostomy tubes imported from China which are valued at Rs.66 lakh on MRP. The wholesaler outlet, Ambika Enterprises at Sultanpet in Bengaluru violated the Drugs and Cosmetics Act & Rules as it was found to stock and sell the medical devices without the valid import licenses, under Form 10 and Form 41, Karnataka drugs controller BT Khanapure told Pharmabiz in an interaction.
This is a major haul and the stockist did not seek required approval from the Drugs Controller General of India (DCGI) to even get his premises registered under Form 41 and seek import licence via Form 10 from the DCGI. Our State Intelligence Bureau needs to be lauded on their efforts to nab the violator. We have commenced our investigation on the same, stated drugs controller Khanapure.
Specific to the cardiac stents, where NPPA disclosed the names of 24 hospitals across the country including two from Karnataka - Philomena’s Hospital and Cauvery Hospital for price violation, we are coming out with a report on the outcome of our investigations. The action will be as per the DPCO 2013, he added.
The law breakers as per NPPA are liable for prosecution under the provisions of the Essential Commodities Act, 1955, stated the Karnataka drugs controller.
The stents prices are slashed by over 85 percent. The department is also ensuring that in the wake of the pricing cut, healthcare providers should not create a scarcity of stents which are critical components in cardiac emergency care interventions. The pricing of these stents levied by the hospitals need to be as per the NPPA order, stated Karnataka drugs controller Khanapure adding that the department will now take stern measures to come down on the violators of these norms. The focus is to ensure both patient safety and affordability, he said.
Moving on to the other developments in the department, the Karnataka DC said that following the state budget allocation of Rs.33.07 crore for 2017-18, the government has granted 25 percent of the total estimated amount of Rs.40 crore for the second Government Pharmacy College in the state at Kalaburagi, a district in north Karnataka. The project is under administrative approval. Post this clearance, construction will be undertaken by the Karnataka Health System Development and Reform Project.