Dinesh Thakur, former Ranbaxy Laboratories Ltd executive who blew the whistle on manufacturing malpractices at the company, has hinted that an effective approach to enforce quality drug manufacturing and export from India would be to downgrade the domestic pharma industry and prevent it from exporting to US till regulators and companies get their act together.
In a working paper titled ‘India’s drug quality under the spotlight with FDA visit,’ Thakur says that?if India wants its companies to export to US, then it should finance and equip its inspectors properly so as to build a cadre of talented, professional inspectors?.
He added that downgrading Indian aviation to category two by the US Federal Aviation Authority is a ?good example to an effective approach to international enforcement?.
?The onus to take corrective action is wholly on the Indian authorities, and the sooner they demonstrate their competence, the sooner their carriers get to expand their operations in the US. This approach provides strong incentive to the Indian government and the industry to get its act together because the financial incentive is huge,? says Thakur.
The working paper is co-authored by Amir Attaran, law and medicine professor at Ottawa university and Roger Bate, author of ‘Phake: The Deadly World of Falsified and Substandard Medicine’.Thakur, Attara and Bate are set to chair a session in Capitol Hill on Wednesday to discuss the threat of substandard and falsified medicines with a focus on India?s quality control failures.
The paper recommends that US Congress should impose severe penalties in the form of trade barriers on any country that repeatedly exports poor quality medicine to the US.
It also proposes that before FDA opens up its inspections dossiers, the Indian regulator should show how it inspects facilities today and ensure quality medicines for Indian patients.The US drug regulator (US FDA) over the past year has hauled up leading India-based firms, including Ranbaxy, Wockhardt, Strides Arcolab for failure to comply with good manufacturing practices, which impacts the quality of the finished product.
According to DG Shah, secretary-general, Indian Pharmaceutical Alliance, ?The violations at a few manufacturing sites are now snowballing into harmful Indian medicines?.
He added that this is an open and protracted attempt at maligning the entire generic industry of India which has helped contain the health expenditure of many governments.
During her maiden 10-day visit to India, Margaret Hamburg, commissioner of the United States Food and Drug Administration, said that Indian companies are not being targeted and are being put through routine regulatory scrutiny required to keep products safe for American consumers.US industry has also urged the Obama Administration to designate India as a Priority Foreign Country, a tag which is given to the worst offenders of patent rights. The only country on the list is Ukraine.
US-based pharma firms have also been putting pressure on India to make its patenting regime ?more liberal.? India?s patent law has provisions that make it difficult to patent incremental pharmaceutical drugs that are not necessarily better than existing therapies in terms of efficacy.
The US is also sore over India not adopting a ?data exclusivity? law that could prevent ?unfair commercial use? of the information furnished by innovator drug companies with regulators by third parties.
