The Central Drugs Standards Control Organisation (CDSCO) is now gearing up to hire 31 technical experts to support the clearances of medical devices and new drug delivery systems. This will strengthen department and speed up product clearances.

“We are in the process of taking a formal consent from the Ministry of Health and Family Welfare and have communicated the need for additional workforce. The qualification of 31 candidates will be biomedical enginnering and candidates from medical technology,” said Dr. E Reddy, joint drugs controller of India, CDSCO.

Dr. Reddy who was addressing during the joint session titled ‘Achieving Global Excellence by Sharing Best Practices’ at the India Pharma 2017 and India Medical Devices 2017 event in Bengaluru said that the hiring is time bound and the selection of these candidates will be taken up at the earliest and will be finalized in the next 3 months.

We need the expert team to extend their know-how in clearances of new products, he added.

From the enforcement team strength standpoint, the DCGI office is expected to hire 1,000 candidates in the next three years. In 2008, the total CDSCO strength was 460 and in 2015 it was 700. In the state drugs control departments too, we will hire around 2,500 candidates. Current strength is 1,700 as against 1,050 in 2008.

The Indian regulatory authority also hires s large contractual workforce to support its service requirements.

“We also set up the National Drug Training Academy in 2015. Already 600 drug regulators have been trained. The job training consists of classroom and field exposure. A gap analysis was undertaken to ascertain the shortfall of information on the latest developments. CDSCO found a need to keep the drug regulators updated and devised the schedule for 21 training programmes. There is assessment before and after training. The Ministry of Health has also mandated yoga classes between 6 am to 7 am. In addition, computer class and personality development are part of the programme. The only missing link is the certification after the training programme. We are now looking to aacrediting the inspectors”, Dr. Reddy said.

Commenting on the clinical trials, he said that India is one country where regulators monitor the compensation to the trial participants. We have designed the consent form, where the participant’s qualification, occupation and income are noted. Another key feature is the audio visual recording of consent process.

In the case of medical devices the regulator has mandated that the companies can seek a onetime license with no renewal. Only in cases where the company license is cancelled , then it will need to renew the same after it complies to the requirement. Another feature is materiovigilance to monitor adverse reactions, he said.