Linking Spurious Drugs with Legitimate Manufacturers Has Severe Reputational, Financial Impact: IPA

There is a need for a clear distinction between spurious and sub-standard drugs as linking counterfeit products with legitimate manufacturers has severe reputational and financial impact, the Indian Pharmaceutical Alliance (IPA) has stated.

The industry body's statement comes in the wake of a recent report by the Central Drugs Standard Control Organisation (CDSCO), which cited more than 50 products as "not of standard quality (NSQ)".

Various drug firms, including Sun Pharma Torrent Pharma, Alkem Laboratories and Glenmark, however, termed the medicines flagged in the central drug regulatory authority's report as "counterfeits" and not manufactured by them while asserting that their products conform to quality standards.

"Manufacturing spurious drugs is a serious criminal offence that threatens public health. The outrageous linking of spurious products with legitimate manufacturers has severe reputational and financial impact. Moreover, this tarnishes India's reputation as a reliable supplier of medicines on a global stage," IPA Secretary General Sudarshan Jain said in a statement.

It is critical that a clear distinction between NSQ and spurious drugs must be made, he added.

Jain said IPA will continue to work with the government to strengthen the overall system and establish stringent measures against spurious drugs.

"This issue is of paramount importance, both for India's global standing and for the protection of public health," he added.

Jain noted that India is the global pharmaceutical manufacturing hub and rightfully recognised as the "pharmacy of the world".

"This sector is of strategic importance to the nation. The Industry plays a vital role in supplying affordable quality-assured medicines to over 200 countries," he noted.

The CDSCO's drug alert for August included samples from batches of medications, such as Shelcal, Vitamin B Complex with Vitamin C Softgels, vitamin C and D3 tablets and Ciprofloxacin tablets.

High blood pressure medications Telmisartan and Atropine Sulphate and antibiotics like Amoxicillin And Potassium Clavulanate tablets have also been categorised as not of "not of standard quality".

While batches of some drugs failed the 'dissolution test' as per Indian Pharmacopoeia and failed the 'Assay' and 'water' test as per IP, some were identified as spurious or having uniformity of volume issues.

IPA represents 23 leading research-based Indian pharmaceutical companies like Sun Pharma, Cipla, and Dr Reddy's Laboratories, among others.