In a move that could be a sign of a changing tide in India, the Ministry of Health and Family Welfare said the government will invest almost $3bn (€2.2bn) to add hundreds of new inspectors for drug manufacturers and other oversight initiatives that could help foreign regulators clamp down on the growing industry.
Within the next six months, India will offer employment to at least 110 new inspectors, Dr. Arun Panda, PhD, Joint Secretary of India’s Ministry of Health and Family Welfare, told in-Pharmatechnologist.com in an interview in his office in Delhi on Wednesday. India currently has about 170 inspectors.
The ramp up of inspections comes as a proposed central drugs authority would take over some of the licensing of manufacturing facilities.
“We’ve said there are 17 critical categories of drugs, including vaccines and monoclonal antibodies, where there will be central licensing for manufacturing facilities,” he said.
The ramp up comes as Dr. Panda admitted that recent tests of about 55,000 finished dose formulation samples in state labs found that nearly 5% of the drugs tested were counterfeit. He conceded that that percentage might be due to sample size and the ministry plans to conduct testing for a minimum of 200,000 samples
“Overall, we understand there are lapses. But we are not really happy with the number of samples,” Dr. Panda said.
The 5% figure also comes as unnamed sources in the media last year accused the country of producing as much as 40% of the world’s drug counterfeits, though that number was declared by the WHO (World Health Organization) to be untrue after Dr. Panda said he personally wrote the organization a letter and questioned where the figure came from and that it was unsubstantiated.
He also highlighted the country’s plan to implement bar codes on all local and exported drugs to further ensure supply chain safety. Secondary and tertiary packaging are already required to have barcodes and primary packaging is on the way, he said.
The vast majority of the government’s new investment will bring more power to state regulators in conducting inspections and issuing manufacturing licenses, Dr. Panda said. For the first time ever, CDSCO (Central Drugs Standards Control Organization) will also oversee the issuance of manufacturing licenses.
“For the very first time, the government of India has recognized that state governments have to be supported financially,” Dr. Panda said.
The funds will strengthen CDSCO’s authority and bring more labs, more capacity, equipment, IT, and archiving capabilities through 2017. Unannounced inspections would also be one of the new capabilities following the investment.
“Manufacturing licenses are given by the states, so the enforcement has to be done by the states,” he added. “Adequate manpower needs to be in place and appropriate training, as well so that they know how to take this matter forward.
“We also have set up new courts in 16 states to fast-track some of the trials” related to the pharma industry, he said.
But the investment comes as some in the Indian generics market are complaining of government corruption and stalled progress in bringing the country up to speed with US and EU standards.
R.C. Juneja, CEO of Mankind Pharma, told in-Pharmatechnologist.com that the government has been slow to issue licenses, invest in strengthening regulations and help industry to export product abroad.
Another generic company CEO who requested to remain anonymous on this issue complained to us of government corruption. But he added that it really only has an impact on the companies looking to do business in India. More multinational companies, such as Jubilant Life Sciences and Dr. Reddy’s, may not see the benefits of this type of investment unless CDSCO and state inspectors begin working alongside the US FDA and European inspection authorities.
New Bill before Parliament
In late August, a new bill that will overhaul much of the Indian drug regulatory system was also introduced in Parliament after ministers began to recognize the growth potential for the sector, Dr. Panda said.
Among other provisions, the bill would create a central drugs authority that would combine relevant ministries, spread the power of issuing manufacturing licenses and create new regulations for medical devices, which until now have been regulated as drugs. Dr. Panda conceded that it is “quite strange” that devices are still regulated as drugs in 2013.
The central drugs authority will have ministers from the 11 ministries, it will have subject matter experts and it will allow some of the manufacturing licenses to be reviewed and suspended, he said.
The separate chapter on clinical trials will amend the Drugs & Cosmetics Act to add new provisions that will put these under the purview of the central authority.
But the timeline for when the Indian Parliament will take up this bill is still up in the air. Dr. Panda said Parliament does not have to take it up by a certain date though he’s hopeful it will be considered this winter.
New Pricing Policy
In addition to the new bill, a new pricing policy that increases the number of essential medicines in India has come to fruition and now places caps on about 25% of the country’s drugs, Shambu Kallolikar, Joint Secretary of the Department of Pharmaceuticals, told In-Pharmatechnologist.com in an interview Wednesday.
When asked if the new policy might cause some companies to pull out of the manufacturing of certain drugs, Kallolikar said there are provisions that stop manufacturers from pulling out of these markets. He also said manufacturers would have to notify India’s NPPA (National Pharmaceutical Pricing Authority) if they want to stop manufacturing any of these drugs.
Both Kallolikar and Dr. Panda stressed the importance of India’s cheap medicines on the world stage and the extent to which more developed countries rely on these drugs.