Chemists' body seeks action against startups for unauthorised tampering, repacking of medicine strips
In a letter dated July 30, the BDCDA claimed that such actions are in contravention of the Drugs and Cosmetics Act, 1940, and Rules, 1945. 'Such tampering and repacking of medicine strips threaten patient safety, undermine ethical pharmacy practices, and erode confidence in the regulatory framework,' the letter stated.
Pointing out that the All India Organisation of Chemists and Druggists (AIOCD) has already taken up the issue of one such startup at the national level, the BDCDA has said that tampering with statutory packaging, unlawfully repacking medicines, and disregarding essential stability and labelling norms by the two health-tech companies put public health at risk.
Specific violations
Highlighting specific violations under the Drugs and Cosmetics Act, 1940, and Rules, 1945, BDCDA president B. Thirunavukkarasu told The Hindu that such actions amounted to willful destruction or removal of statutory labels, batch numbers, expiry dates, MRP, and mandatory warnings - effectively stripping medicines of their legally required safeguards, and thereby endangering consumer safety under Rule 96 and Rule 97 of the Act.
Compromising the stability, potency, and therapeutic efficacy of medicines by exposing them to contamination and temperature variations through improper handling, storage, and repackaging practices amounted to violation of Schedule P1, he said.
GMP and GSP violations
'Carrying out repacking in unlicensed, non-compliant, and uncontrolled environments grossly violates the principles of Good Manufacturing Practices (GMP) and Good Storage Practices (GSP) mandated under the law. Besides, misrepresenting these unlawful and unethical acts as 'tech-enabled innovations', or 'patient-friendly services' mislead consumers and erode the credibility of India's ethical pharmacy community,' he said.
Apart from all these violations, the sale of medicines through online platforms continues unchecked, lacking any legal authorisation or structured regulatory mechanism, Mr. Thirunavukkarasu added.
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