Compulsory registration for import of drugs and pharmaceuticals was introduced by the DCGI more than three months ago on April 1. Since then there has been a fall in the import of a number of undesirable bulk drugs and formulations into the country, an objective the government wanted to achieve for some time. The decline in imports of bulk drugs is particularly noticeable from China since April with DCGI clearing less than 30 applications from China up to May 15. Unrestricted imports of cheap bulk drugs from China were one main reason for the closure of several small bulk drug units in India since nineties. Like bulk drugs, there has also been some check in the inflow of various substandard diagnostic products into the country with the inclusion of these items also under compulsory registration. Although the registration system has brought some control in import of substandard products and a relief to the domestic industry in a short span of three months, it will not be wise to assume that this regulatory measure will remain totally effective. For that the office of the DCGI has to tighten its registration procedures. Clearing of import registration applications by just screening will not be enough. As per the registrations norms, DCGI has the power to inspect foreign manufacturing facilities before clearing the applications. As the DCGI's office does not have adequate number of technical experts, the government should allow DCGI to seek the help of the pharmaceutical experts from the industry for carrying out such overseas inspections.
Be that as it may, an issue that needs to be immediately addressed to is the timely clearance of applications for import registration with the DCGI. A large number of applications for registration from established suppliers are lying with the DCGI office. Delays in clearance of applications are already causing concern to the industry as such delays could cause shortages of essential medicines in the country on account of interruption in supplies of production inputs. For a large number of essential drug formulations, India is currently depending on foreign suppliers. It is important to note here that the office of the DCGI has constraints to function efficiently because of the inadequate number of technical experts and poor infrastructure. That is no fault of DCGI. In this regard, the suggestion made by IDMA that DCGI should grant provisional registration within 30 days of application, is understandable. But that should not be done indiscriminately. In the case of well-established manufacturers and suppliers, granting of provisional registrations could be safe. By making it a standard practice, there is a risk of substandard and dangerous materials getting into the country defeating the very objective of a registration system.