The Drugs Control General of India (DCGI) has embarked on a multi pronged strategy to strengthen the drug regulatory system and infrastructure facilities in the country. As part of this, soon the Central Drugs Standards Control Organization (CDSCO) is planning to launch 20 mobile drug testing labs and recruit 200 more new drug inspectors in the next few months.

In addition to this, the DCGI is also upgrading the existing drug testing laboratories, and enabling capacity building and skill development of its workforces by way of providing regular training and sending them to workshops and joint inspections with US FDA regulators. The DCGI is also enhancing the penal sections of Drugs & Cosmetic Act to take stern actions against violators.

During the past two years the DCGI has already recruited 350 drug inspectors and is expected to appoint 200 more in the next few months. To speed up the testing of drug samples, the drug controller is in talks for collaboration with USP and German regulators for procuring the required technology, mini testing kits, mini sophisticated equipments to be installed in the mobile vans.

Already one mobile testing van is introduced in Gujarat for pilot study. Once this gets successful, the DCGI is expecting to launch many more such mobile vans for testing drug samples in the remote areas. “Money is not a criterion for us; we are spending close to Rs.8 crore for each mobile drug testing van. These vans will have all necessary advanced equipments that will enable onboard drug inspectors to collect drug samples from the remote and faraway places in the country and instantaneously test them for their quality,” said, Dr G NSingh, DCGI.

The mobile drug testing vans will be installed with very small and most sophisticated equipment for analyzing the drug samples. For this, the DCGI is procuring them from Germany and also taking help from United State Pharmacopoeia for making this project a success in India. “We want to launch these mobile testing vans in remote areas of Uttar Pradesh, Bihar, Jammu and Kashmir and Telangana,” said the DCGI.

AS India has already made it mandatory for the Indian pharma companies to comply with GMP and GLP norms way back in 2009, the DCGI is now working on strengthening it and monitor the same on a regular basis. The DCGI is also embarking on adopting new practices and procedures in its regulatory system to make it more robust and stronger. “Wherever there is a new development, we want to adopt it and incorporate it to ensure that our pharmaceutical industry produces best quality drugs. As part of this we are sending our regulators to joint inspections, training programmes and workshops. We are also continuously updating the Indian Pharmacopoeia and incorporating new procedures and drug testing methodologies from time to time. Not just upgrading our regulatory frame work, but equally we are strengthening our infrastructure and manpower resources,” said the DCGI.

To complete the fast testing of thousands of pending drug samples, the DCGI is also planning to take help of information technology and is expecting to install advanced software for the same. “Our scientists have developed unique software for testing the samples at a faster rate. Moreover we are also planning to launch an international alert system, to help us identify drawbacks and help us fill the gaps wherever necessary, this will be launched in the next 6 months,” said Dr Singh.