The Central Drugs Standard Control Organization is starting a series of surprise checks at various drug manufacturing units throughout the country next month onwards. The inspection exercise is being undertaken in the face of innumerable complaints coming in from the US Food and Drug Administration(FDA) about faults in the manufacturing plants leading to manufacture of sub standard medicines.
Following the inspection pattern of the US FDA, the CDSCO is planning to undertake aggressive surveillance that would help weed out units that happen to be deviating from the standard manufacturing practices , thereby, compromising on patient safety. This move comes amidst growing concern about the deteriorating quality standards of medicines in the market. The CDSCO’s aim through these surprise checks is to ensure that sub standard medicines do not gain entry into the consumer market.
The exercise is primarily aimed at ensuring that the local market isn’t flooded with substandard medicines.The future checks to be undertaken are also meant to ensure that Schedule M of India’s Drugs & Cosmetic Rules 1945 requirements for good manufacturing practices (GMP) certification and Certificate of Pharmaceutical Products as per World Health Organization (WHO) guidelines are adhered to while companies undertake manufacture of medicine in their plants.
According to Economic Times the changing severe stance of the CDSCO comes in the face of warning letters issued by the FDA to various leading pharma units for faults at their manufacturing sites and major deviations of quality. The CDSCO has threatened punishment if the poor performance in terms of quality manufacture is detected in the future. Some of the prominent names on the FDA fault list being: Sun Pharma, Cadila Healthcare and Dr Reddy’s.”We may even issue suspension or cancellation of licences. In cases of major deviations, we may also (take legal action) against the company,” stated one of the controlling authority official.
Talking about standards of quality for local and international markets maintained by Indian manufacturers, a GMP consultant said, “It is not a secret that some Indian companies follow two sets of standards; one for local-level consumption or supplies to markets that have a lower bar for regulatory acceptance and the other for developed markets like the US and EU,” It has also been observed that Indian regulators haven’t been as harsh as the FDA and other international agencies against local manufacturing facilities.
In 2014, a Drug Consultative Committee had outlined focus areas for inspection such as : establishing shelf life, conducting validation studies and ensuring prompt and effective recall besides the WHO GMP requirements.”In cases of critical observations which have a direct impact on the quality, safety and efficacy of the products and where regulatory actions has to be initiated immediately, reports are to be finalised at the end of the inspection, without delay,” the committee had noted.
The Central Drugs Standard Control Organization has already earmarked 20-30 sites for inspection in the first phase, wherein 3 member teams would be sent to carry out inspections. The body plans to undertake surprise audits with the help of 15-20 teams that have already been appointed stated one of the CDSCO officials adding that inspectors had already been trained for this purpose.
The apex standard control body in an effort to strengthen its task force plans to employ 1000 people at both the centre and state level, 250 out of these would be employed for the inspection wing. This is being done to bring under control all quality related lapses threatening the Indian pharma industry.