India Spending $500 Million To Increase Drug Oversight Powers

India has announced that the government will be spending approximately $500 million in order to increase the capacity of the country’s drug regulators. With the investment, India will be doubling the number of drug inspectors in the country in the next three years. The regulatory departments currently employ 800 officials, though this number is expected to hit 3,000. The government also aims to increase the number of inspectors at the Central Drugs Standard Control Organization (CDSCO) from 500 to 1000. The increase in drug inspectors and government infrastructure will help to ensure that Indian drug products meet international standards.

“India believes in safety, efficacy and quality of drugs and is organizing the system to maintain standards,” said G.N. Singh, national drug controller. “We are also planning to harmonize the standards in all the states with a central regulatory system.” Singh continued to say that the improvements would be gradual, and that all ports would eventually gain infrastructure allowing the government to check all drug shipments before they left the country.

In recent weeks, India has been beleaguered by western regulatory bodies and multinational pharmaceutical companies, stating that the nation needs to be proactive in ensuring drugs produced in the country meet the regulatory standards necessary to export to global markets. Following several visits from the U.S. regulatory body to inspect factories and meet with Indian pharmaceutical companies over the past few months, India’s government has vowed to work with the FDA.

Indian government officials have acknowledged that the country will have to address its drug standard, and that safety and efficacy should take a step ahead of cost. There are more than 10,000 drug manufacturing factories in India, and recently there have been a rash of FDA bans on certain drug imports.

India also is looking to improve its intellectual property system, which multinational drug companies have criticized in past years. "India's reference system (for drug testing and intellectual property) will be at par with the top world standards in two to three years and will even match the U.S. in three to five years," Singh said.