By Apoorva Misra,Himani Chandna,News18

Copyright news18

India’s top drug safety adviser has dismissed concerns linking paracetamol to risks in pregnancy, calling the claims unproven and urging that any suspected side effects be reported through the country’s pharmacovigilance system.
YK Gupta, national scientific advisor, Pharmacovigilance Programme of India (PvPi), told News18 that any suspected side effects of paracetamol will be examined under India’s pharmacovigilance system, but to date, no scientific evidence exists to link the drug with harm in pregnancy or causing autism in an unborn child.
“If anyone in India has any such observation with the use of paracetamol, it should be reported to the Pharmacovigilance Programme of India. If reported, this can be taken up under vigilance,” Gupta, former dean and head of the pharmacology department, All India Institute of Medical Sciences (AIIMS), New Delhi, said.
The Pharmacovigilance Programme of India (PvPI) is a government system under the Union Health Ministry that monitors and reports adverse drug reactions to ensure the safety of medicines in the country.
Gupta emphasised there is no cause for alarm. “As of now, there is no need to be in panic mode as we do not have any scientific evidence,” he said.
US President Donald Trump has urged pregnant women to avoid Tylenol, the brand name for paracetamol, citing the unproven linkage to autism. The warning, issued on Monday, came as the US drug regulator announced plans to add a label cautioning about a possible increased risk of autism and attention-deficit or hyperactivity disorder in children.
The remarks prompted a swift backlash from doctors and scientists, who stressed that evidence so far shows only associations—not proven cause and effect.
The brand Tylenol sold in the US is the same drug we commonly know as paracetamol. It’s one of the most widely used medicines in Indian households, sold under brand names like Crocin and Dolo.
No drug can be labelled ‘safest’ in pregnancy
Paracetamol, widely used for fever and pain relief, has long been considered safe in pregnancy. “Paracetamol is considered to be the safest analgesic and antipyretic drug. However, as we know, all drugs should be given with caution during pregnancy—not just paracetamol but all other medicines as well. Especially in the first trimester, when the organs are in the formation stage, in general, all drugs should be avoided. This advice is not new but very commonly known,” he said.
Gupta, now president of AIIMS, Kalyani (West Bengal), explained that certain medicines, such as thalidomide and some oncology or neurology drugs, are strictly prohibited in pregnancy due to proven risks. “Then there are categories of drugs which are known to cause harm in animals but not in humans. We place those drugs in the caution category,” he added.
Regarding paracetamol, he pointed out that it has been extensively studied over the course of several decades. “All drugs in India are launched only after extensive testing, including an assessment of their teratogenic and neurological side effects. Paracetamol has been used for ages, and there are no side effects reported that prove any direct linkages.”
The only established risk, Gupta said, concerns the liver. “Earlier, the safe dosage limit was 12 grams per day, which was later reduced to 4 grams. Up to 2 grams a day is considered safe for human consumption. Hence, so far, there is no other causation or direct linkage to establish its impact on an unborn child.”
On recent studies raising red flags, he was categorical: “We cannot rely on weak linkages or observational studies to promote such claims. Large-scale studies would be required to prove these linkages and establish causation. Therefore, there is no reason for panic or alarm.”