NEW DELHI – A new report to the government of India suggests the adoption of a slew of measures to help domestic pharma firms, especially small firms that form the bulk of the industry, better understand the global regulatory landscape and meet compliance standards in advanced countries.

The report comes in the wake of a number of drug quality issues raised by the FDA after a series of inspections. Those issues, often linked to a handful of manufacturers in a field of thousands, can hurt the entire national industry, one that is among the largest in the world.

India's pharmaceutical industry should understand that the entire "brand India" suffers from irregularities observed by international authorities in the products of a few Indian companies, Krishna Ella, founder of Hyderabad-based Bharat Biotech, which unrolled the world's cheapest rotavirus vaccine in March, told BioWorld Asia. Ella said most of the problems in the case of Indian drug firms arise from a lack of stringent documentation during the manufacturing and testing process.

"Data integrity is the root cause of all issues being faced by India," he said.

A report released in June by by Ernst & Young backs Ella's view, saying data integrity issues persist in the Indian pharma industry. Data integrity, inadequate validation during manufacturing and testing, and cases of product contamination were among the issues that have come out during FDA inspections.

"The problems encountered by the FDA's investigators in India are similar to those seen around the world in manufacturing," said an FDA spokesman.

The FDA's office in India, set up in 2008, works with Indian regulators, who have become "important strategic partners for the FDA" on a range of issues from clinical trials to product safety, which may impact U.S. consumers, he said.

He said the FDA India office ensures that Indian manufacturers shipping to the U.S. "understand the risk associated with their product's processes," are compliant with the FDA's regulations, and food and medical products are safe and of high quality.

It is with all those goals in mind that a commission has put forth its recommendations in a report, titled "Recommendations of the Task Force on Enabling Private Sector to Lead the Growth of Pharmaceutical Industry." India's Minister for Chemicals and Fertilizers, Anant Kumar, recently announced the measures.

Among the key recommendations is the creation of a high-level coordination committee to periodically review the constraints that the pharmaceutical industry faces. Smaller companies are often handicapped by low levels of investment and limits on growth beyond their allocated space in industrial clusters with "antiquated environment standards."

Another recommendation is for India to set up regulatory cells within the National Institute of Pharmaceutical Education and Research (NIPERs) and other institutes to help the sector better understand the global regulatory landscape. The regulatory cells in NIPERs would play a key role in capacity building and infrastructure support. Those cells would work closely with international regulation-focused bodies such as the Centre for Innovation in Regulatory Sciences in the UK, the Drug Information Association in the U.S. and the Centre for Regulatory Excellence at the Duke-NUS (National University of Singapore) Graduate Medical School.

A third recommendation is for the Department of Pharmaceuticals under Kumar's ministry to provide financial assistance to help drugmakers meet the highly regulated standards set by the FDA, European Directorate for the Quality of Medicines, Australia's Therapeutic Goods Administration, the UK's Medicines and Healthcare Products Regulatory Agency and other regulatory agencies.

Other recommendations include strengthening India's Central Drugs Control Standard Organization by recruiting more drug inspectors to control and monitor units. The report noted abysmal deficiencies in that regard. Some 3,200 drug inspectors are needed to monitor the 600,000 pharmaceutical retail outlets and 10,500 manufacturing sites. India has just 846 inspectors on the job, not enough to even fill 1,349 posts that have been approved.

The report also recommends improving infrastructure support by setting up cold chain facilities and formulation development centers to tap into opportunities that might arise from molecules going off-patent in the next two years.

Another suggestion is to set up a promotional body or registered society to create brand awareness campaigns.

INCREASING PRESSURE

The task force report comes at a time when the fragmented Indian pharmaceutical industry is under increasing pressure to meet the high regulatory standards of developed countries. Most of its nearly 10,500 drug manufacturingunits are small with just 300 to 400 of them considered medium or large-scale factories.

And yet, India's pharmaceutical industry is the third largest in the world by production volume and the 14th in terms of value. The industry supplies about 10 percent of total drug production and 20 percent of the total global volume of generics drugs.

India is also among the top 20 pharma exporting countries. Exports to some 200 countries, inlcuding the U.S., Russia, Australia and Germany, make up around 50 percent of total turnover of the industry.

Drugmakers in India and elsewhere in Asia are looking to expand to new export markets while raising the quality of the drugs they export, even as they tap into new opportunities. A report by Frost & Sullivan suggests companies in the region might be able to capitalize on opportunities created by molecules going off patent between 2015 and 2017. Multinational pharmaceuticals are responding by opening generics divisions.