The drugs control authorities on Monday froze the sale of 400 finger-tip pulse oximeters worth around ₹7.19 lakh here over labelling issues even as traders question the alleged arbitrary enforcement, which they accuse is bad in law.
The sale was prevented on the charge of non-display of specifications in labels as prescribed by the Medical Devices Rules 2017. However, no case has been registered yet as a direction from the Drugs Controller is being awaited. The operation was conducted by a team led by Saju A., Drugs Inspector, Office of Assistant Drugs Controller, Ernakulam.
The pulse oximeters were priced at ₹1,799. The State government had fixed the maximum retail price of pulse oximeters and 14 other medical products under the Kerala Essential Services Control Act last month to avert over pricing during the pandemic.
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A shop dealing in diagnostic kits had reportedly procured them from a Chennai-based dealer importing electronic goods from China. The drugs control authorities said that this was a common arrangement and cited how dealers at the electronic street at Pallimukku here imported pulse oximeters and sold them to dealers of medicines and surgical devices over WhatsApp groups. Their prices get doubled down the chain and the products available for around ₹250 eventually get sold in the retail market for ₹1,799 now.
Guarantees
“The exorbitant prices are charged citing guarantees, though the manufacturers offer no such guarantees. Also, the guarantees are not honoured on the ground that products once used by COVID-19 patients cannot be taken back,” said a drugs control official.
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A.N. Mohan, State president, All Kerala Chemists and Druggists Association, however, alleged that the price regulation of medical products was disconnected from the reality and done arbitrarily without any consultations with competent authorities or stakeholders. He observed that there was no legislation stopping licensed electronic goods dealers from importing pulse oximeters and it was for the authorities to stop unlicensed operators.
No clarity
“There is still no clarity on the specifications for pulse oximeters or uniformity in enforcement. Shortcomings should be taken up with manufacturers rather than penalising traders. How can there be different parameters in one State for products sold across the country,” he said.
He alleged that overruling the Drugs and Cosmetics Act and the Legal Metrology Act applicable in the sale of medical devices was bad in law and said it was the reason why enforcement under the new regulations was not followed by registration of cases. “Many products were notified under the Medical Devices Rules recently and the Centre had given 18 months for registration and compliance with provisions as the existing systems cannot be overhauled overnight,” said Mr. Mohan.
Quality varies
The All Kerala Surgical and Scientific Dealers Association said that fixing uniform price without differentiating between quality was problematic. “Products priced below ₹1,000 were of inferior quality while superior quality ones were priced around ₹2,000. Law-abiding traders cannot afford to undersell them unlike operators who evade taxes,” said Devadas R., State president of the association.