Post-marketing surveillance of approved drugs not complied with by pharma companies

The post-marketing surveillance system in the country is in shambles, putting the patients at risk without effective monitoring of the side effects by some drugs, if the recent findings by the Parliamentary panel are to be believed.

There is a poor follow-up on the side effects in Indian patients both by doctors and manufacturers, as per the report by the Parliamentary Standing Committee attached to the Health Ministry which found that even some drugs which were not `officially launched’ were available in the market.

Once new drugs are approved, rules require that manufacturers submit post marketing Periodic Safety Update Reports (PSURs) listing side effects, fatalities, injuries etc. in Indian patients once every six months in the first two years and then annually in the following two years.

“In order to scrutinize the compliance of this rule, the Health Ministry was asked to furnish PSURs in respect of 42 randomly selected new drugs. Since files in respect of three drugs were reportedly missing, PSURs should have been supplied for the balance 39 drugs. The Committee is, however, constrained to note that PSURs in respect of only 8 drugs were submitted by the Ministry. The Committee was informed that 14 drugs though approved were not being marketed or were launched lately and hence PSURs would be expected later. There was no explanation for not submitting PSURs in respect of rest of 17 drugs,” the panel report said.

“Out of 14 drugs that were reported to be either not yet launched or lately launched, the Committee discovered that, at least, two products (FDC of glucosamine with ibuprofen; and moxonidine) were indeed in the market for some time and concerned manufacturers should have submitted PSURs. But the Committee has not been given any explanation for non-submission of PSURs for these two drugs,” it said.

The panel also found that the PSURs were not being submitted in time as per the rules. In the case of two drugs of MNCs (dronedarone of Sanofi Aventis and pemetrexid of Eli Lilly), the PSURs were neither India specific nor in the approved format as required by law. Some companies submitted PSURs for the products being marketed in the country but very few PSURs were India-specific, according to the panel.

“The Committee strongly recommends that the Ministry should direct CDSCO to send a stern warning to all manufacturers of new drugs to comply with mandatory rules on PSURs or face suspension of Marketing Approval. PSURs should be submitted in CDSCO-approved format which would help track adverse effects discovered in Indian ethnic groups,” the report said.
by
Dr.Akshaya Srkanth,
Hyderabad