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In a significant regulatory action aimed at preventing substandard medicines from reaching patients, the Maharashtra Food and Drug Administration (FDA) has permanently cancelled the ayurvedic manufacturing licence of Pune-based Inducare Pharma Pvt. Ltd. after finding multiple violations of Good Manufacturing Practices (GMP), the Drugs and Cosmetics (D&C) Act, 1940, and the D&C Rules, 1945.
The decision follows repeated inspections, a show-cause notice, a personal hearing and a joint inspection, during which the company failed to provide a satisfactory explanation for the deficiencies. The action also comes after six of the company's ayurvedic medicines were declared substandard by the Government Analyst.
Commenting on the action, Tukaram Mundhe, Commissioner, Maharashtra FDA, said, "Ensuring the availability of safe, high-quality, and effective medicines to citizens is the paramount responsibility of the Maharashtra FDA. It is mandatory for pharmaceutical manufacturers to strictly adhere to the D&C Act, 1940, the rules framed thereunder, and GMP standards. Strict regulatory action will be taken against any manufacturer found negligent regarding the quality of medicines."
The Maharashtra FDA has intensified regulatory oversight of pharmaceutical manufacturing units to ensure that only safe, quality and effective medicines are available in the market. As part of this drive, the regulator has permanently cancelled the ayurvedic medicine manufacturing licence of Inducare Pharma Pvt. Ltd., located at Jejuri MIDC in Pune district, citing serious violations of statutory quality standards and manufacturing norms.
According to the Maharashtra FDA, inspections of the manufacturing facility were carried out on two separate occasions as part of its regular and risk-based surveillance programme. During these inspections, officials identified significant non-compliance with the provisions of the D&C Act, 1940, the Rules framed under the Act in 1945, and the mandatory Good Manufacturing Practices prescribed under Schedule T for ayurvedic medicines.
The regulatory action followed a detailed enforcement process. After the inspection findings, the company was issued a show-cause notice and provided an opportunity to present its explanation during a hearing. A joint inspection was also conducted. However, the FDA said the company failed to satisfactorily address the deficiencies identified during the investigations, prompting the permanent cancellation of its manufacturing licence.
The inspection revealed widespread deficiencies across manufacturing, documentation, quality assurance and facility maintenance. Officials found no documentary evidence to establish that ingredients specified in the approved ayurvedic formulations had actually been used during manufacturing. Batch Manufacturing Records were found to be incomplete and inconsistent, lacking critical information such as raw material batch numbers, analysis report references, production process details, weight variation records, yield calculations and distribution records. The absence of these records prevented the regulator from verifying whether medicines had been manufactured in accordance with approved formulations and quality standards.
Maharashtra FDA inspectors also found that records relating to the cleaning of manufacturing equipment, machinery logbooks and process validation were unavailable. Documentation for quality testing of raw materials and excipients was also missing, indicating gaps in the company's quality control systems.
Further concerns emerged regarding microbiological testing. Although records indicated that microbiological analysis had been carried out, inspectors found that the facility lacked the laboratory infrastructure, equipment, culture media records and positive controls required to perform such testing.
The production area itself was found to have several deficiencies. Inspectors observed poor cleanliness, damaged sieves and flooring, unclean suction filters, oil deposits and the use of paper inside production machinery, practices that could compromise manufacturing quality. The facility also lacked a hygrometer required for monitoring temperature and humidity during production.
The Maharashtra FDA further reported that essential quality management system records, including those related to pest control and packaging materials, were absent. It also found that certain ingredients specified in approved formulations had not been used in the manufacture of some medicines.
The regulator identified additional shortcomings in the company's product traceability system. Distribution and sales records for medicines linked to complaints were unavailable, making it impossible to establish complete traceability of the affected products.
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