Drug regulator gears up to tighten surveillance

The country’s drug regulator is gearing up to strengthen the surveillance system, to improve the quality of medicines manufactured by domestic companies and those imported from other countries.

The Drug Controller General of India (DCGI) has identified several challenges coming in the way of improving the quality of drugs and is preparing to address them.

“It is widely believed that there are huge quantities of spurious drugs in the market. But, it is far from truth. However, it is a fact that there are not-of-standard-quality drugs being sold and we have to effectively address this,” Surinder Singh, the drug controller general, said while addressing a conference of the Bulk Drug Manufacturers Association (BDMA).

Singh said the samples collected and tested so far show about 0.2% drugs are spurious while 5-6% are sub-standard.

“Today, the drug industry is worth about `1 lakh crore including an export component of about `45,000 crore. About 5-6% of products not complying with the set standards is actually huge,” he said.

The presence of sub-standard drugs is being linked to the non-availability of proper infrastructure rather than deliberate act of some drug companies.

“In most of the towns, the pharmacists to not have facilities to maintain a cold chain. For instance, capsules can withstand up to 40 degrees temperature. There are some drugs that become ineffective after 20 degrees. The quality issue of drugs has a lot to do with the infrastructure available with the pharmacists as well,” he said.

Before moving in on the issue, the DCGI is strengthening its manpower base. “Till recently, we had 18 drug inspectors covering about 8,000 drug units. We know it would cause a lot of quality issues. We have started working on that and we are recruiting officers. Once all the posts are filled up, we will have about 327 people. Still, even this manpower is not enough to ensure that the sector is properly regulated,” Singh said.

The DCGI, he said, collects about 40,000 samples for testing every year. “There is a scope for collecting at least 2 lakh samples. But the infrastructure and manpower constraints do not allow us to go beyond what we are doing now. This is grey area. The number of sub-standard drugs could be much higher than what we have found so far since a majority of samples are not being tested by us,” he said.

Pharmacovigilance is another area the DCGI is working on. This is a science concerned with detection and prevention of adverse reaction of any drug.

“There is nothing called pharmacovigilance in our country. We are now working on strengthening it by involving medical colleges and hospitals. We have 300 medical colleges in addition to various hospitals as part of this. To begin with, we have shortlisted 40 medical colleges, with AIIMS as the national co-ordination centre on pharmacovigilance. In the next two years, we will involve all the 300 medical colleges, private hospitals including Apollo and Fortis and government programmes like TB, leprosy and immunisation under the ambit of pharmacovigilance,” Singh explained.

The lack of an evolved pharmacovigilance system means DCGI depends on data provided by agencies like the US FDA for taking a decision on any drug.

“We have to have our own data on drug reaction for us to take a decision on banning or dropping a drug. That will help us at least in putting a box warning to alert the patients about the expected drug reaction… we are depending on data provided by others for taking a decision,” Singh said.

The drug regulator is also attempting to bring discipline in clinical trials.

“It is widely believed that India is emerging to be a hub of clinical trials, which is not true. While about 49-50% of trials are done in the US, just about 1-2% of global clinical trials are done in India. There is a long way to go to for us to be a global trials hub. But, the day is not far off and we have to be prepared for that,” Singh said.
DCGI is also preparing its personnel to conduct the inspection of drug facilities overseas. “Countries like Nigeria, Brazil and South Africa too are sending their officials to inspect the drug units before allowing imports. We will also start doing that since there are large quantities of drugs being imported from China or the EU. Only after DCGI officials are satisfied about the quality at the exporter’s facilities will we allow the Indian companies to import drugs,” he said.