Central drug regulatory authority is planning to start testing new drugs, especially those from the multinational companies before they launch in the country. The testing will be done in notified labs instead of current practice of relying on the claims made in the support documents submitted for marketing approval.
However, this will be done only after taking a series of steps to equip the government labs with the advanced equipments to carry out the tests. At present the government and private labs in the country are not fully capable of undertaking the tests for new drugs, sources said.
One of the plans underway in this regard is to tie up with the NABL accredited labs in the private sector for the purpose. The DCGI office has already initiated some tie-ups with the private labs with this goal. But currently, the agreement will be limited to getting the samples tested by them. The DCGI office is planning to carry out regular surveys to ascertain the spurious and counterfeit drugs, by picking up samples randomly from the market. As the government labs cannot do it at one go, the samples will be sent to the private labs also for testing.
DCGI office had recently collected 24,000 samples as part of a national survey to ascertain the quantum of spurious drugs in the country. The target is to collect at least one lakh samples in the coming years, in phases and the assistance of private labs are being sought in this regard. It has also tied up with NGOs to collect the samples to make the study more effective.
"We will be entering into MoUs with the private labs and the samples will be sent to them. Later, this working collaboration can be expanded to cover the testing of new drugs also. New drugs need very high end equipment which is very cost intensive. These could be imported or be developed. We are just going by what the manufacturer is saying at present. We want them to test them also. So we could identify these government labs, which are NABL accredited, we could notify them and even look at notifying some of their scientists as government scientists for this purpose. Our people can also associate with these notified private labs for testing samples and new drugs," sources said.
It is learnt that the DCGI office has already identified six private labs and is working on the concept paper for the MoU, detailing the revenue model and other formalities. However, it will require an amendment to the rules in the Drugs and Cosmetics Act and the DCGI office will be taking it up with the concerned quarters in this regard, sources added.