In March this year, the drug regulators of various countries such as the US, Australia and Denmark issued safety alerts against one of Abbott’s latest-generation stents, as it was found to be increasing the risk of major cardiac events. Following this, on April 7, India’s central drug regulator issued a medical device alert asking the doctors and patients to report any adverse events related to the use of two latest-generation stents of Abbott Healthcare. Almost two months have passed, but India’s regulator has not received even a single report of adverse event till May 26.
The April 7 alert of the Central Drugs Standard Control Organisation (CDSCO) was against two latest generation stents of Abbott Healthcare — Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS. The CDSCO had said in this alert: “Based on the three years’ clinical data analysis from ABSORB II, it has been observed that there is an over elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis.” The alerts of USA, Australia and Denmark were against Absorb GT1 BVS only.
When The Indian Express asked the CDSCO, through an RTI application, about the number of adverse event reports after the issuance of the April 7 alert, the latter replied: “This office has not received any complaint on adverse event after April 7, 2017.” The CDSCO letter, sent as a response to this newspaper’s RTI application, was dated May 26, 2017.
When CDSCO was asked — in this newspaper’s RTI application — if it has told Abbott to conduct phase 4 trials for aforementioned two stents, it replied : “The matter was discussed in the Subject Expert Committee – (Cardiovascular and Rental) held on April 18, 2017. After detailed deliberation, the committee opined that the firm has to come up with future plan and each patient implanted has to be systematically followed up in a registry/phase 4 trial and protocol has to be submitted for examination and approval. The same has been communicated to the firm and this office is waiting for the reply.”
When Abbott was asked as to why they have not replied to this committee’s communication regarding phase 4 trial requirements and protocols, the company spokesperson told The Indian Express: “Abbott has been engaging with CDSCO on an ongoing basis and is currently working on responding to its requests.”
On February 13, the NPPA had capped the prices of coronary stents — the price cap on Absorb GT1 BVS was not kept at a higher level as requested by the company. Interestingly, while the SEC told Abbott to conduct phase 4 trials with proper protocols on April 18, the company told the National Pharmaceutical Pricing Authority (NPPA) on April 21 that it wants to withdraw Absorb GT1 BVS from the Indian market as its sale has become commercially unviable after the stent price cap. Five days later, the NPPA rejected Abbott’s withdrawal application, stating that the “statutory Form IV” attached with their “request letter” has not been “duly signed”.
On February 13, the ceiling prices of bare metal stents were fixed at Rs 7,260 per piece and that of drug eluting and BVS stents were fixed at Rs 29,600 apiece. On March 31, the price caps were increased by NPPA to Rs 7,400 and Rs 30,180, respectively.
While rejecting the stent withdrawal application, the NPPA added a caveat regarding one of Abbott’s stent against which international regulators have taken action. The pricing regulator stated in its April 26 memorandum: “However, if Abbott Healthcare India Ltd. finds that ‘Absorb BVS’ cannot address the ‘safety concerns’ already raised by USFDA, EU, TGA-Government of Australia, CDSCO and others, the company can approach NPPA at any time before the period mentioned in 5(a) above, clearly stating the reasons for withdrawal to be ‘safety concerns’.” The pricing regulator also advised Abbott “to be more cautious and responsible in taking such business decisions in the light of government’s commitment to ensure affordability and availability of all essential drugs to the people”.