The revised Schedule Y of the Drugs & Cosmetics Act, which is to be announced shortly, is likely to cover the bioequivalence and bioavailability studies of existing drugs on human volunteers as well. A new set of rules and regulations to be followed for conducting these studies is to be incorporated in the Schedule before it is released.
Currently the Schedule Y of the Drugs & Cosmetics Act deals only with studies of new drugs on human i.e. clinical trials. However, a fresh thought among the Central Drugs Standard Control Organization (CDSCO) officials including the Drug Controller General of India (DCGI) towards bringing the BE and BA labs under regulatory scan has led to the preparation of a new mandatory guideline for such studies.
According to informed sources, a draft guideline in this regard would be prepared and submitted to the DCGI in a week. In addition, the CDSCO has also invited expert views from outside the department to suggest various options and methods to put regulatory control on the hitherto unscrutinized BE/BA studies of drugs in the country.
By including BE studies in the Schedule Y, the institutions and hospitals conducting bioequivalence and bioavailability studies of drugs are to come under the direct monitoring of the DCGI.
With this move, the licensing of the BE study centres and labs would become mandatory and the studies should get due approval from the DCGI. Currently, there is no requirement for any kind of approval from either DCGI or any other authority as per Drugs and Cosmetics Act, 1940 to conduct such studies.
Since the studies are conducted on the existing drugs and they were not conducting clinical trials on new drugs, this area was so far ignored by the government. However, recently a number of controversial cases have been reported across the country in connection with unethical drug studies on human volunteers.
In India, at least 24 major institutions and another 60 small laboratories and hospitals are conducting BE/BA studies on human volunteers for pharmaceutical companies for the purpose of new formulations. Since there is no official recognition for such institutions or individual approval of such studies existing now, any drug testing/analysis laboratories and hospitals can conduct bioequivalence tests of existing drugs in healthy human subjects.