52% families surveyed have had 1 or more members face unknown side effects from medicines; 85% want it to be mandatory for manufacturers to display main side effects on the packaging or via a leaflet

September 7, 2023, New Delhi: Yesterday, the Drug Controller General of India (DCGI) advised patients and healthcare professionals to stop using Digene gel, a popular antacid, due to safety concerns. Drugmaker Abbott has initiated a voluntary recall of the impugned product. The World Health Organisation (WHO) in June red flagged seven Made-in-India cough syrups after in its probe into complaints from several countries of these products being contaminated and having caused several health complications. The probe by the UN organization had found high levels of diethylene and ethylene glycol in the cough syrups that led to several deaths across the globe. In the same month, the Government of India banned 14 fixed-dose combination (FDC) medicines, which contain two or more active ingredients in fixed dose ratio, as they were found to lack therapeutic justification by an expert panel. In fact, the expert panel had observed that “there is no therapeutic justification" for these FDC and may involve "risk" to human beings. In the larger public interest, the notification, issued on the basis of recommendations of the Expert Committee and the Drugs Technical Advisory Board, stated that it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940. At regular intervals, the Central Drugs Standard Control Organisation (CDSCO) flags medicine batches which have failed to qualify on quality yardsticks. In July, it flagged 51 batches of medicine for being “not of standard quality” including widely used medicines like Rosuvastatin manufactured by Sun Pharma Laboratories, drug combination Tamsulosin Hydrochloride and Dustasteride tablets manufactured by Cipla.

LocalCircles has received thousands of inputs in the last 6 months from citizens raising concerns about safety of medicines in India. To quantify the concerns of families with medicines, especially around side effects, LocalCircles conducted a national survey. The survey received over 22,000 responses from citizens located in 341 districts of India. 68% respondents were men while 32% respondents were women. 43% respondents were from tier 1, 32% from tier 2 and 25% respondents were from tier 3, 4 and rural districts.

Over 50% respondents or their family members have experienced side effects of medicines prescribed by doctors in the last five years

The first question in the survey asked respondents, “How many times has it happened in the last 5 years that someone in the family including yourself took medicine(s) and experienced side effects that the doctors prescribing did not make you/them aware of?” In response, 52% respondents indicated that they or their family members have experienced such an ordeal. Out of 11,082 respondents to the query, 34% indicated that their family members have had such an experience once or twice in the last five years. Among the remaining, 6% shared that such incidents had happened more than 10 times in the last five years; 3% indicated 6-9 times; 9% stated 3-5 times. In all, only 30% shared that they had not undergone such an experience while 18% were unsure.

85% surveyed believe “it should be mandatory for medicine manufacturers to disclose the main side effects on the packaging / via a leaflet along with it”

Focusing on the patients and caretakers right to know about the side effects, if any, of taking a particular medicine, the survey posed the next question where it asked, “Do you think it should be mandatory for medicine manufacturers to disclose the main side effects on the packaging / via a leaflet along with it” an overwhelming majority of 85% state “yes, absolutely”. Among the 11,096 respondents to this query, 11% consumers felt such a measure is not practical and another 4% felt it was not needed. Given that in India several prescription drugs are still sold over the counter with the chemists not demanding a Doctor’s prescription, there is a strong need to inform the public about the possible side-effects. With such information published on the medicine package or shared via a leaflet (print or electronic), a patient can be informed about these possible side effects.

In summary, the survey finds that over 50% of the citizens surveyed or their family members have suffered due to unknown side effects of the medicines prescribed to them in the last five years which is a very sizable number. With so many cases reported over the last 12 months where medicines were found to be unsafe or had an unknown side effect, the survey shows that this is real and impacting people in India. In addition to the Central and State Drug Controllers doing all possible to ensure safety of medicines, citizens are keen that side effects of medicines be presented to them more transparently and effectively. 85% citizens in the survey want that it be made mandatory for medicine manufacturers to list the main side effects of every medicine on the packaging or via a leaflet (paper or electronic) that is shared with them when buying the medicine.