The sampling exercise started by Drug Controller General of India (DCGI) in States like Jammu and Kashmir, Himachal Pradesh, Maharashtra, Tamil Nadu, Maharashtra, Rajasthan and Chhatisgarh last year will now also be taken up in North Eastern (NE) states to assess the quality of drugs in the coming months.
Against the backdrop of the fact that several drug manufacturers have continuously received warnings and import ban orders from the US Food and Drug Administration (USFDA), DCGI is planning to renew its focus on states like UP, MP, Bihar, Rajasthan and other NE states for scrutiny on drug quality and GMP standards.
DCGI believes that current regulatory requirement has to be viewed from an Indian perspective, rather than a direct comparison with developed markets. A senior CDSCO official informed that around 77 samples were collected for analysis at Chhatisgarh and around 60 drug samples at Rajasthan during the random sampling as a part of the exercise meant to keep a stringent check on the quality of medicines. “It will be an ongoing exercise in coordination with state drug regulators to enhance enforcement for arriving at drug quality. The exercise would sensitise state drug regulators in enforcing GMP standards more stringently,” DCGI Dr G N Singh asserts.
The exercise involves the process of drawing samples of medicines from public healthcare institutions and retail pharmacies. The samples are then sent for testing to government authorised labs across the country to check their quality and efficacy.
Last year, India-made medicines were losing sheen the world over, due to constant alerts from international drug regulators. Against this backdrop, DCGI wants to ensure quality in the domestic market. Incidents such as the Chhattisgarh sterilisation tragedy, followed by the Punjab eye cataract mishap, have added to the worsening view of Indian healthcare.
While the FDA is tightening its stand on generic drug makers, Indian stakeholders feel adequate resources are lacking to improve GMP in India. The Indian regulator has 1,200-1,500 officers; the FDA has close to 13,000. Experts believe 20,000 officers would be required to adequately inspect all drug facilities.
A total of additional 1195 posts were sanctioned for the upgradation of manpower and labs under the 12th five year plan. Central Government has allocated Rs. 900 crore for enhancing manpower and capacities of minilabs at port offices and mobile labs at CDSCO level.
India has a little over 10,000 manufacturing drug units. Informs a CDSCO official, "We expect to double the manpower and enhance the lab infrastructure both at the centre and states by the end of 2017. CDSCO has also conducted 17 training programmes to train drug inspectors on carrying out GMP inspections in the year 2013-14 to ensure quality of drugs supplied to over 200 countries from India."
"The practice of deputing drug inspectors as observers through joint inspections has been able to help draw suggestions and feedback from our global regulatory counterparts on continuing GMPs. It will help manufacturers in adopting global practices followed in other countries where our medicines are consumed," he adds.
He further said that US FDA's workshops on GMP and CGMP compliance for the first time in four cities of India in partnership with Central Drugs Standard Control Organisation (CDSCO) last year has been well received as over 60 pharma companies participated in the workshop.