Instead of cough syrup testing, need to go for root-cause analysis: Bhaskar

Pharmaceutical exports from India have come under the scanner after sporadic incidents of contaminated or substandard medicines

Pharmaceutical exports from India have come under the scanner after sporadic cases of contaminated or substandard medicines. These incidents have led the government to ask cough syrup exporters to test their batches at central drugs laboratories (CDLs) before them shipping abroad. Udaya Bhaskar, director general of the Pharmaceutical Exports Promotion Council (Pharmexcil) in a telephonic conversation with Sohini Das shares his views on the matter. Edited excerpts:

How are pharma exports from India doing in 2023-24?

Last financial year, India exported $25.4 billion worth of pharmaceutical products, registering growth of 3.25 per cent year-on-year (YoY). For the current financial year, we have data for April and May: In April, there was 10.45 per cent YoY growth, the highest in the recent past for a month; in May, however, growth slipped, clocking only 0.78 per cent YoY growth. When both months are taken together, the export growth rate of 5.1 per cent, so far, this year. I am expecting that in FY24, our pharma exports will touch $28 billion. The general growth rate is around 5 per cent. We have seen good growth in the European and US markets. This financial year, there is 10.47 per cent growth in the US market; Brazil has recorded 29.2 per cent growth. Against a contraction last year, the UK has recorded a 12.58 per cent growth rate. The problem has been the African region where exports witnessed contraction last year – down by about 5-6 per cent. In the African region this year, there is growth of 4.9 per cent over the same period of last year (April-May). Last year, the reasons for the African region not doing well in terms of exports were a reduction in spending by NGOs, which buy our HIV, TB, and malaria drugs for the region, economic and political crises in some of the countries, and inventory build-up due to excess buying during the Covid-19 period. Africa has a 14 per cent share in India’s exports. So, it’s an important market.

Did you face any apprehension among buyers when you visited Africa recently?

In the initial months after the incidents in The Gambia and Uzbekistan, there was a sense of concern among industry players, country regulators, and overseas buyers. They always used to enquire about what is happening -- they were asking some of our big exporters about what exactly is happening. They wanted to know why something like this was happening, and if there was indeed any question of quality in our exports. However, now, after the CDSCO (Central Drugs Standard Control Organisation) has taken some positive steps, people are not seriously pursuing this matter anymore.

Do you think testing export-bound batches of cough syrups at central drugs laboratories (CDLs) will delay shipments?

Now several guidelines have come up on testing: For example, The Gambia recently came up with guidelines to test pharma products from India before them being shipped. Nigeria has always had a rule of testing samples before they were exported. Cough syrup exporters now also need to get tests done at CDLs before they are approved for export. Also, manufacturers test products made at their site and submit a certificate of analysis (CoA) as part of existing guidelines. So, there are several levels of tests happening. For a cough syrup consignment, there are now three levels of testing – manufacturers’ CoA, CDL testing, and country-specific testing (as applicable).

I feel that once guidelines are in place, it is the manufacturer’s duty to adhere to them, and the regulator’s duty to ensure compliance. Quality is a continuous process. Instead of asking the industry to send cough syrup samples for testing, we need to frame guidelines for the same. We need to identify companies that make these cough syrups and ask them for information about vendors that supply the ingredients in question like propylene glycol and diethylene glycol, etc, and also identify states from which these are coming. We need to go for root-cause analysis.

Today we have an issue with cough syrups, which account for around $15 million of our exports. If tomorrow, any other product, which has a much higher volume and value, comes under the scanner, testing samples at CDLs will become a tedious task. We cannot make decisions based on aberrations.

There are millions of batches going for exports, and only a few batches have had problems, but those were enough to dampen the image or perception of the pharma industry here. Therefore, we need to focus on continuous quality assurance.

How many memberships have you suspended or cancelled in the wake of these incidents?

We have suspended memberships of four-five companies, so far. However, we are not the regulator, so our action is limited to seeking information from our exporters. In case exporters have not satisfactorily responded to the information sought (related suppliers, etc) from them, we have gone ahead with the suspension of memberships.