Mumbai: The wrongdoing by Ranbaxy Laboratories Ltd, which was caught falsifying data and forced to reach a $500 million settlement with the US Food and Drug Administration (FDA), could end up smearing India’s generics manufacturers as producers of substandard medicines that harm the patients who take them.
The Indian government is convinced that there is a deliberate campaign to give the country’s companies a bad name.
“There are reasons to believe that vested interests are raking up isolated issues reported regarding technical deficiencies on manufacturing practices,” the commerce ministry said in a press release posted on its website.
Not only that, the government accused other nations of trying to frame Indian companies.
“India is enjoying a unique position of low-cost manufacturing and highest quality medicine. Government has strong reason to believe that some of the spurious drugs detected in the international markets, alleged to be exported from India, are desperate attempts by other countries getting affected by the strength of Indian pharma industry,” the release added.
Incidents such as the one involving Ranbaxy Laboratories are exceptions and may be amplified by “vested interests” seeking to halt India’s dominance of the generics or off-patent drugs business, the ministry said.
“There have been extensive media reporting in the print as well as electronic about on the quality of drugs manufactured in India for exports. Some isolated reports have also been received about export of spurious or counterfeit drugs attributed to some source in India,” the release added.
On 13 May FDA and Ranbaxy reached a settlement under which the Indian company, now owned by Japan’s Daiichi Sankyo Co. Ltd,agreed to pay a penalty of $500 million.
Separately, on 25 May, Wockhardt Ltd announced that it has received an import alert from US FDA on its plant at Waluj in Aurangabad in Maharashtra.
Mint reported on 26 May that both events were certain to give Indian generics a bad name.
The ministry’s release would appear to be a reaction to the events, and the coverage they attracted. Mint has previously reported extensively on the lacunae in India’s drug regulatory regime.
In its release, the commerce ministry said that India’s pharmaceutical sector is a highly regulated one. It further added that there is a work-in-progress mechanism for continuous monitoring of quality-related aspects including complaints of substandard drugs from various countries.
“All the concerned organizations in the government are constantly interacting to ensure that India’s image as a safe exporter is protected from all angles. Government and the industry are already working on a ‘trace and track’ mechanism that would enable monitoring of the supply chain...,” the ministry said.
The statement comes in the wake of efforts by various industry bodies to shore up the image of the Indian pharma industry.
The Pharmaceuticals Export Promotion Council of India, the Indian Pharmaceuticals Alliance, even the Organisation of Pharmaceutical Producers of India, the foreign drug makers lobby in India, have all clarified that the manufacturing and quality issues are specific to certain companies and can’t be generalised.
At stake is India’s generics business worth an estimated Rs.1 trillion.
The country is one of the top generic drug exporters to the US with about 323 manufacturing plants approved by FDA, and employs around 2.5 million people. The release from the ministry said Indian companies have proven capabilities to match international standards as measured by the number of generic drug approvals, the large number of manufacturing facilities approved by regulatory bodies such as the US FDA, and the UK Medicines and Healthcare Products Regulatory Agency.
“These are considered as key indicators for assessing the capabilities of any national pharma sector, and this fact is further firmly demonstrated by the trends in the number of product approvals received from various major regulatory authorities of the world,” said the Monday release from the ministry.
India’s generic drug exports to global markets including the US and European Union touched $14,590 billion in fiscal 2013, according to data released by Pharmaceuticals Export Promotion Council in April. The country is also the largest drug formulations exporter by volume currently with a 14 % market share in the world drug market.
The government is also seeking to put in place a tracking system for the local market as well as exports.
“Steps being taken to ensure the authentication process for trace and track under way. The ministry of commerce is in talks with the ministry of health in the matter seeking common approach for both exports and domestic tracking.”