Having received tip-off about serious lapses due to non-compliance of provisions under Schedule M of the Drugs and Cosmetics Rules, 1945, a team from the Central Drugs Standard Control Organisation (CDSCO) headquarters in Delhi, along with the east zone office of CDSCO and state drug officials conducted surprise raids at three premises of pharmaceutical companies of Uttarakhand, Sikkim and Daman.
Manufacturing licenses of around 50 companies has been suspended following this raid. Out of the 118 or so products which were found in the investigation, 70 were being manufactured without the CDSCO’s approval, but instead licenses were granted by the state authorities.
The manufacturing units were found violating good manufacturing practices (GMPs) and requirements for the premises, manufacturing plant and equipment for pharmaceutical products.
With an uncompromising attitude towards quality of drugs and bench-marking standards for effective compliance, Drug Controller General of India (DCGI) Dr S Eswara Reddy, who is at the helm of affairs at the CDSCO spearheaded the raids just after he took charge in February 2018. Further to this, he has his plans chalked out for the future as well with strategies to strengthen drug regulatory mechanism in the country, manpower, infrastructure up-gradation and creating the much awaited Indian Drug Services (IDS) cadre much on the similar lines like Indian Administrative Services (IAS) cadre.
Following raids, notices were also issued by the department of health care, human services and family welfare, of the drugs and cosmetics cell of the Government of Sikkim.
The raids were targeted at companies which manufacture drugs that have not been approved in India. In the case of Daman, the drugs have not been approved for manufacturing anywhere in the world.
The CDSCO conducted raids in Sikkim on April 19 and April 20, 2018 in collaboration with state drug officials. They raided two drug manufacturing firms– Savi Healthsciences and Savi Pharma.
The firms were found to have been manufacturing new drug formulations of ulipristal, dienogest and azilsartan, without the approval of the CDSCO. Ulipristal is an emergency contraceptive which is used to prevent pregnancy after the failure of other birth control measures; dienogest is a hormonal drug used to treat endometriosis in women; azilsartan is used to treat high blood pressure.
The firm has been procuring drugs in bulk for these formulations from unregistered sources, risking the lives of the patients. The drug regulator cancelled Savi Pharma’s license and ordered the firm to discard all the processed tablets, capsules and sterile products as per Sikkim Pollution Control Board norms, with intimation to the office of the undersigned.
Savi Healthsciences was found to be manufacturing medicines even while construction activity was underway in their premises. The inspection team has found that the firm is carrying out construction activity in the same premises without taking precautions for preserving the raw materials and packing materials. Company was also not maintaining records of its activities.
These two manufacturing firms were ‘loan-licensees’ for East West Pharma. Under a loan-license, companies outsource manufacturing to other units but market it under their own name.
The CDSCO also carried out another raid on Olive Healthcare in Daman, which was manufacturing enclomiphene, a new drug that has not been approved yet. This drug is used to treat deficiency of the male hormone, testosterone, in men. According to government officials, enclomiphene has not been approved in India or by any international regulatory agencies.
Olive Healthcare was also found to be illegally procuring unapproved active pharmaceutical ingredients (APIs). Ten drug inspectors from the CDSCO headquarters in Delhi, Mumbai and Ahmedabad, came to Daman for the raid.
Two companies in Uttarakhand were raided in March. Big companies like Wockhardt found themselves in trouble, along with others like Mascot Health and Ambic Aayuchem.
These companies had been procuring and marketing drugs, even without approval from the CDSCO. They had also failed to carry out safety trials. The drugs they had been manufacturing included fixed dose combinations for treating diabetes and fungal infection.
According to a government survey, between 2014 and 2016, out of 47,012 samples which were tested across the country, only a small percentage of drugs have been found to be of a poor quality – 3.1% of drugs were seen as not conforming to accepted quality standard and 0.0245% of drugs were found to be spurious.