Introduction:
In a decisive move to tackle quality issues in pharmaceutical excipients, the Drugs Consultative Committee (DCC) of the Union health ministry has recommended stringent measures. The recent meeting, chaired by Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi, emphasized the necessity of adhering to the Drugs and Cosmetics Act for the use of only pharma-grade excipients.
Recommendations and Advisory:
The DCC proposed issuing advisories to State Licensing Authorities (SLAs) to direct manufacturers to use pharma-grade excipients exclusively. To further delve into the matter, a sub-committee is set to be constituted, providing a comprehensive report within three months.
Regulatory Intervention:
Addressing concerns about the quality of pharmaceutical inactive bulks, the DCC is contemplating regulatory interventions. Recent risk-based inspections revealed instances where excipients like glycerin and propylene glycol, imported as industrial grade, were used in drug formulations, posing potential risks to public health.
Global Implications:
International complaints and accusations by the World Health Organization and health ministries in importing countries, including Gambia, have drawn attention to cough syrups manufactured in India, citing unacceptable levels of contaminants. The DCGI has directed against purchasing propylene glycol from specific suppliers, impacting the reputation of Indian manufacturers in export markets.
Adulteration Concerns:
The committee highlighted cases of adulteration, with technical/industrial grade gelatin from China being used in capsule manufacturing. This practice poses health risks, and organizations like Nagrik Upbhokta Margdarshak Manch have reported capsule manufacturers unknowingly using industrial grade gelatin from China in capsules intended for human consumption.
Industrial-Grade Challenges:
Concerns extend to the import of low-cost industrial/technical grade gelatin mainly from China, being blended with high-quality gelatin in India for capsule manufacturing. Similarly, the use of industrial-grade isopropyl alcohol (IPA) in the pharmaceutical industry, imported from various countries, poses dangers to health as it may not meet pharmacopeia standards.
Regulatory Framework:
The DCC emphasized existing rules, highlighting that excipients imported under Dual Use NOCs should strictly be used for non-medicinal purposes. The definition of drugs under the Drugs and Cosmetics Act includes all substances intended for use as components of a drug, emphasizing the need for compliance with GMP and manufacturing licenses.
Conclusion:
The DCC’s proactive measures underscore a commitment to ensuring the safety and quality of pharmaceutical products. Addressing these issues is crucial not only for public health but also for maintaining the reputation of Indian manufacturers in the global pharmaceutical market. Stay tuned for updates on these regulatory developments shaping the pharmaceutical landscape.
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