India’s Pharmaceutical Regulatory Challenges and “Just-In-Time” Services

Many drug companies have been reporting delays in obtaining drug product approvals and licenses in India. Not only must drug companies deal with product reviews and regulations from the Central Drugs Standard Control Organization (CDSCO), but companies also often need approvals or licenses from state level regulators. This often means additional procedural delays and confusion.

However, the CDSCO says that approval times have become faster for new drug applications and clinical trial permissions. In addition, the CDSCO is investing in opening new offices and hiring and training regulatory personnel. Moreover, the Health Ministry is working on guidelines and policies for the online sale of medicines.

Over the past several months, the CDSCO has implemented its “just-in-time” services program, covering several key areas: speeding up regulatory clearance for drug export licenses, fast tracking indigenously developed drugs, and expediting certain certificates to conduct bioavailability and bioequivalence studies in India.

Furthermore, the government is speeding up approvals for personal licenses so that individuals can import drugs or vaccines in medical emergency situations. The products do not need to have marketing approval in India, but should have approval in other key markets, such as the U.S. or EU.

India has also announced that it plans to introduce an online system for all pharmaceutical regulatory applications within the next two years, further reducing the amount of time required to obtain a pharmaceutical product license or approval in India.