With a view to speeding up procedure to trace spurious drugs and initiate actions against the guilty, the health ministry has initiated a number of steps like fixing the time-limit for testing the drug samples collected by the drug inspectors and asked the States to follow the deadlines to the maximum extent possible.
The ministry also requested the Indian Pharmacopoeia Commission (IPC) to provide reference standards to the government testing labs within the next four-to-six months so that the labs can speed up the testing procedures.
Following the observations that the drug testing laboratories were delaying the process which leads to delay in corrective actions, the Ministry has issued general guidelines to be followed by the labs. Pharmaceutical products with HPLC (high performance liquid chromatography) should be tested within 90 days and products without HPLC should be cleared within 45 days, subject to the availability of method of analysis, the ministry said.
The ministry also asked the State health departments to ensure adequate financial provision for drawing more number of samples by the drug inspectors. As per the present provision, drugs inspector shall draw the samples only after payment of the cost of the drugs. The fund allotted for the purpose, are generally insufficient and thus, the provisions of the Drugs and Cosmetics Rules pose a hindrance in drawing sufficient number of samples for test/analysis.
Though the time-limits were fixed for testing, the ministry however did not put any deadline for launching prosecutions in the court against spurious/sub-standard drug cases, considering the practical difficulties. There was also a growing demand to define time-limit for the same, as there is no such provision in the Drugs and Cosmetics Act.
However, the States have pointed out that the drug inspectors could initiate action only after necessary investigations at the place where the samples are drawn and also where the drug manufactured. This exercise in most of the cases is of interstate nature and time consuming. As such it may not be feasible to prescribe time limits for launching of prosecutions, it was pointed out.