Close on the heels of raids by Central Drugs Standard Control Organisation (CDSCO) on two drug makers in the state for manufacturing new drug formulations of ulipristal, dienogest and azilsartan without approval of Drugs Controller General of India (DCGI), Sikkim drug regulatory authority has cancelled manufacturing licence of Savi Pharma and suspended manufacturing licence of Savi Health Science.
Both firms are loan licencees of parent firm East West Pharma. As per Drugs and Cosmetics Rules, 1945, permission from the office of DCGI is required before new drugs are licensed by state licensing authorities (SLAs) for manufacture, sale in the country.
CDSCO in its endeavour for furthering the quality of medicines in the country conducted raids on Savi Pharma and Savi Health Science on April 19-20, 2018. The raids were conducted by CDSCO officials from its headquarters in New Delhi and east zone office in Kolkata in association with state drug officials.
During the raids, both drug makers were found violating the provisions of Schedule M of the Drugs and Cosmetics Rules, 1945, dealing with good manufacturing practices. The two firms had the same technical staff making supervision of their activities impossible as the activities were carried out parellelly.
The officials found that the firm was procuring the bulk drugs for new drug formulations from unregistered source risking the lives of the patients.
Acting swiftly, Drugs and Cosmetics Cell, Department of Health Care, Human Services and Family Welfare, Sikkim had on April 20 cancelled manufacturing licence of Savi Pharma and directed the company to discard all the processed tablets, capsules and sterile products as per Sikkim Pollution Control Board norms.
During the raid, the officials found that Savi Health Science was carrying out construction activity in the same premises without taking precautions for preserving the raw materials and packing materials. The firm was also not keeping record of its activities.
The state drug regulatory authority had suspended manufacturing licence of Savi Health Science.
Earlier in April the CDSCO officials raided Olive Healthcare in Daman, which was manufacturing enclomiphene, a new drug that has not been approved yet.
In March 2018 acting on an information that certain FDCs falling under the new drug category of Drugs and Cosmetics Rules, 1945 were being manufactured by Ambic Aayurchem and Mascot Healthcare in Uttarakhand without DCGI approval, CDSCO along with state drug authority and local police had raided the premises of both companies.