Why the Maharashtra FDA can’t control the sales of sub-standard hand sanitizers
The joint commissioner of Food and Drugs Administration (FDA) in Maharashtra talks about the difficulty of ensuring quality against the surge in public demand
After the outbreak of covid-19 in India, the demand for hand sanitizers went through the roof. The Union government thus issued a circular in March asking the state governments to ramp up production “on a priority basis". The state food and drug administrations (FDAs) were asked to issue licences within three days of receiving an application. The new rules also allowed sugar mills and distilleries to manufacture hand sanitizers.
Today, there’s no shortage of sanitizers in the markets. But as Mint reported in July, many new products sold in the last few months bypassed the FDAs rigorous testing processes and licensing requirements. As Abhay Pandey, president of the All Food and Drug License Holders Foundation, a body of over 200 medicine and medical equipment suppliers in Maharashtra, told Mint at the time, “In the absence of licensing processes, there’s no way of knowing if they conform to quality standards..."
A report released earlier this week by the Consumer Guidance Society of India (CGSI), a Mumbai-based consumer body, confirms this. In August, the CGSI sampled and tested 120 hand sanitizers sourced from Mumbai and Thane. Nearly 50% of the samples tested were found to be adulterated. Five per cent even contained methanol, a toxic chemical that can cause blindness.
Mint spoke to Sunil Bharadwaj, joint commissioner (vigilance) at the Maharashtra FDA, on his agency's efforts to counter sub-standard sanitizers in the market, the difficulty of ensuring quality against the sudden surge in consumer demand, and how the FDA is working with half its sanctioned strength, which comes in the way of them doing their job effectively. Edited excerpts from the interview:
The CGSI study found over the 50% of the 120 hand sanitizers tested in Mumbai to be adulterated. Four per cent were found to have contained toxic methanol....
This survey is done by a private organization. They have published a report but I haven’t received it officially. We will have to see how they have collected and tested the samples.
But since the pandemic started, we have had round-the-clock monitoring. From February to August, we raided 55 unlicensed manufacturers of hand sanitizers. We also seized sanitizers worth ₹2.4 crore across Maharashtra. We collected 57 samples from the market, got 50 of them tested and found 19 of them of sub-standard quality. We have also ordered prosecution in 15 cases.
Aren't 57 samples too less compared to the number of new products in the market?
Frankly, we were looking after (quality-control of) masks and other work also. There are no written guidelines on how much number we have to (seize). But if we suspect anything, if we receive any information, we initiate action.
Would you say that manpower constraints also affected your work?
That is true. Compared with the population and the number of (sanitizer) manufacturers, we have got very less manpower. We have got a total of 89 drug inspectors for the entire state. We’re running short of 50% staff. Given the circumstances, we are performing our best.
In March, the Union government had issued a circular instructing state governments to ramp up sanitizer production “on a priority basis". The state FDAs were asked to issue licences within three days of receiving an application. Do you think quality was compromised in pursuit of quantity?
No, I don’t think so. While issuing licences also quality is ensured. And we are checking samples also.
Can that be achieved in three days?
As you are aware, there was a huge (sanitizer) crunch because of the pandemic. The government took the decision to issue licences. With certain undertaking and certain documentation, licences were issued and it was made binding on (the manufacturers) to maintain quality.... When the licence was issued, the manufacturers had to test and submit the (quality) report to the FDA. It was only after submission of the report that they could sell the product in the market.
How about site inspection, checking if the premises are hygienic, if the people manufacturing have the right qualifications? Was this given a short shrift?
I can’t comment on that.
In June, a Maharashtra FDA official had alleged to me on the condition of anonymity that the licences were issued soon after a licence fee was deposited, without any inspection of the premises.
There are always exceptions.... Pandemic isn’t a common occurrence. It was the Central government’s direction (to issue licences), hence it was done. Even in the case of manufacturing of masks and the PPE (personal protective equipment), the government has allowed to manufacture (the kits) and then apply. A limit of 18 months has been given to apply for licences (for PPEs). This is an exception made for the pandemic.
How do we ensure quality after the products are in the market?
Again, licences were issued to cope up with the requirement. The FDA is also drawing samples to check the quality. This is done because the government has taken decisions because of the pandemic.
Do you intend to take any action in the wake of the CGSI report?
If we find substance in it, we will definitely act on it. There will be more checks too. As I mentioned, there is some limitation due to manpower constraints. But we are definitely trying to increase the number of our tests.
FIRST PUBLISHED04.09.2020 | 11:00 AM IST