As Demand For Quality Drugs Increase, Lack Of Funds Hampers Safety Revamp

New Delhi, 13 Feb 2018: As the need for good quality drugs is growing in India, states are grappling with the lack of adequate manpower and other facilities that can make inspections easier. Until recently, the Andhra Pradesh drug controller did not even have an office to operate from, according to a submission of the director-general of the Drug Controller Administration of Andhra Pradesh.

In a recent drug consultative committee meeting, drug controllers from various states like Maharashtra, Gujarat, Goa, Odisha and Andhra Pradesh pointed out that they were finding it difficult to strengthen the regulatory system as funds were not being released. These states and others manage the ₹ 1 trillion Indian pharmaceutical industry.

The numbers

A Ravi Shankar, director-general of the Drug Controller Administration in Andhra Pradesh told Business Standard that the two issues confronting it related to human resources and infrastructure. “There is one inspector for 700 shops while the recommended strength according to World Health Organisation (WHO) standards is one inspector for every 200 retail outlets,” he said. In Maharashtra, there were 100 drug regulators for 80,000 retail units and 6,000 manufacturing units, said an official of the Maharashtra Food and Drug Administration.

Apart from the workforce, the infrastructure to seize drugs is also a problem. Drug controllers state that cold chain facilities are not available, making seizure of drugs difficult.

Gujarat is another state that has a sprawling pharmaceutical industry. Its drug controller, H G Koshia, said here, too, there was a shortage of inspectors but the state was trying to adopt digital methods to inspect drugs. “Our position is not as bad as other states, but we are short of inspectors,” he said. There are 100-odd inspectors for 4,000 licensed manufacturers and 37,500 retail outlets in the state.

The ratio should be one inspector for 50 manufacturers.

Lack of support from the Centre

Andhra Pradesh is home to many leading pharmaceutical firms, especially those that export drugs. Keeping the amount of exports from the the Visakhapatnam port in mind, a joint administrative complex was planned, but it has not been executed yet. This is because the commerce ministry has not yet worked out a revenue generation model or the logistics.

The Centre not sanctioning funds has also limited states in setting up drug price violation cells. Like Gujarat and Maharashtra, there are states where separate drug price violation cells are yet to be set up.

The idea of a drug price violation cell was first mooted in 2015 by the department of pharmaceuticals to look into drug pricing issues. These states claim the Centre has not yet released funds to set up these cells.

The Budget has sanctioned ₹ 2,060 million in 2018-19 to strengthen the drug safety regulators in states as opposed to ₹ 523.5 million in 2017-18. Though the allocation has been increased, these funds might not make much of a difference unless the infrastructure is enhanced at the state level. Business Standard