Despite the seemingly stringent import registration system for drugs in India, large quantities of inferior quality drugs are flowing into the country mainly from China, it is learnt. The union health ministry had made the import registration mandatory for all drug substances since 2002 to ensure the quality of drugs entering into the country.

Gujarat Food and Drug Control Administration had recently seized a number of inferior quality products after testing the samples by the state drug testing laboratory. It was found after the test that most of the materials originated from a few suppliers from China. The GFDCA reveals that in several cases formulation sample tests, it is found that the active ingredient in the samples were substantially inferior in quality or the stability factor is notably low.

In Gujarat, 11 such cases have been detected following routine sample tests and also after complaints from patients and other state departments. Recently, 10 cases spurious/inferior products, wherein loperamide hydrochloride and jentamycin formulations, were seized from the markets. In all the ten cases, it is found that the active ingredients were either of low quality or nil.

Though it was found that the raw material sourced through imports were defective, the FDCA had no option but to take action against the formulator. And in certain cases, the manufacturing licenses have been permanently terminated by the state FDCA.

Since the poor stability of the Chinese imported APIs is the mostly detected quality issue, the products get cleared in the preliminary tests. So, the buyers (formulators) in India also get duped by the suppliers. But in such cases a detailed analysis by the government labs is required at the entry point. As the import registration is in place since 2002, the site examiners and quality analysts attached to the office of the DCGI should have the system of such detailed analysis to check the entry of inferior quality products.

Interestingly, the CDSCO officials said that though all the required sample tests and data submission were done to ensure the product quality in the import registration procedures, they were not aware that to what extent these formalities are followed by the department and how efficient were the people who were supposed to analyze the data and samples.

"Moreover, there is a need for random testing at the time of consignments to ensure the consistent quality of materials. However, effective implementation of this procedure is not being conducted as a part of the audit of registered imports," a senior official alleged. "Overall, the quality assurance while allowing imports is to be significantly improved," the officials commented.

However, often these defects are found when the formulation samples are collected from the market and tested by the state drug control departments. That means the defective or harmful products are detected only after it reached the market. By this time, some patients are already the victims.

Hence, the state departments wonder how these products were cleared by the Central authority instead of stopping the entry by not granting the registration.