Recent warnings and crackdowns from US FDA and its Indian counterpart CDSCO have again brought the grave danger that adulterated and substandard products that pharma manufacturers are putting out in a largely unaware and uneducated market.
- USFDA recently reproached Global Pharma Giants for adulteration and testing violations of drugs produced at Indian facilities
- Indian drug regulatory body CDSCO inspected and found 45 illegal manufactures of medical equipment with substandard products
- Indian pharma sector has a long history of cheating regulations as well as patients through faulty equipment and counterfeit medicine.
- USFDA actions won’t impact Jubilant’s sales for the Roorkee plant as only 4% goes to US; but what about the countries where the plant sends rest of its products
Recently, the USFDA sent warning letters to a number of Indian Pharma giants. The likes of Jubilant Lifesciences, Aurobindo Pharma, and Biocon have been reproached by the USFDA for serious violations in their drug test and manufacturing processes.
US drug regulator had issued a warning letter to Jubilant Life Sciences for its Roorkee facility in Uttarakhand. The facility was inspected by USFDA in August 2018. As per note from the USFDA webpage, the warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
It also said that drug products at Jubilant Roorkee Facility were adulterated as their methods, facilities, and controls etc. were non-conformant. Jubilant Life Sciences in an intimation to the BSE has said:
“The United States Food and Drug Administration (USFDA) may withhold approval of any new applications or supplements till the company addresses all issues raised by the agency,”
Indian Pharma has a knack for bending norms
The Indian Pharma Sector has been on a collision course with drug testing and regulation authorities for quite some time. India is the world’s largest exporter of generic drugs, making almost 40 percent of all new generics the FDA approved in 2018 through October. It is a major supplier to the US drug ecosystem.
Over the years, USFDA has a history of finding grave violations at Indian factories from open toilet drains found at a sterile facility owned by Mumbai-based Wockhardt Ltd. to malfunctioning equipment at one of Dr. Reddy’s Laboratories’ plants in South India.
In a similar incident, the Indian counterpart of USFDA, the CDSCO cracked down on illegal manufacturing of orthopaedic implants. Having gathers significant and substantial intel over two months of investigation, CDSCO carried out surprise inspections on March 11 and 45 unlicensed manufacturers were unearthed. S Eswara Reddy, Drug Controller General of India (DCGI) said:
“29 firms and five traders were found manufacturing or selling ortho implants without licenses. A lot of these unlicensed manufacturing activities are being carried out in Delhi, UP, Gujarat and Maharashtra”
As per CDSCO’s report, manufacturing activity was being performed in dirty, filthy conditions at the facilities. They found a lack of quality management systems and no signs of a testing laboratory. The report said that ‘traders were assembling the products and selling them on their own as manufacturers’.
November 2018, saw the Union health ministry approved a formula for determination of compensation for patients with faulty ASR hip implants supplied by Johnson & Johnson. Thousands of patients are to be compensated between Rs 30 lakh to Rs 1.23 crore.
Earlier in 2017, the expose from The Indian Express investigation as part The International Consortium of Investigative Journalists (ICIJ) investigation campaign called ‘Implant Files’ found how the first Bill to regulate medical devices was drafted 12 years ago but still hadn’t been enacted. The expose also brought into limelight malpractices by global pharma majors pushing devices such as coronary stents, pacemakers, breast and knee implants into markets via a dubious nexus with hospitals and doctors.
In another 2017 incident, players like Pfizer, Dr Reddy’s Laboratories, Alembic Pharma and Cipla were among 66 drug makers that had some of their products failing quality tests carried out by the country’s drug regulator CDSCO.
In 2013, India’s Pharma big gun Ranbaxy pleaded guilty in a US court to several criminal offenses relating to fraudulent manufacturing and sale of adulterated drugs. Ranbaxy’s executives revealed that ‘over 200 products in more than 40 countries’ were affected by ‘elements of data fabricated to support business needs.’
Pharma majors often put business before ethics
Often, companies in question ignored the aspects of purity and transparency in drug manufacturing, which should be the holy grail of the business. As per FDA, although bad laboratory practices are usually at the root of such violations, in India there have been high-profile cases of overt and deliberate fraud.
Recent frauds have put pharma manufacturing culture in India under such particular scrutiny that USFDA increased inspections in India by 18 percent last year, underscoring the fact that India poses the FDA’s biggest challenge as it struggles to ensure drugs are cheaper but also safe.
India’s low production costs are a terrific opportunity for global pharma industry to realize the dream of affordable medicine for everyone. But the fact that Pharma giants are more concerned with what impacts revenue and market value, rather than ground level best practices, is a grave cause of concern.
The USFDA started pushing for India’s pharmaceutical and medical device regulators up to speed with international norms in 2016 with new cooperative training sessions. They have conducted training sessions for over 200 Indian regulators, the majority of which were new inspectors, representing the Central Drugs Standards Control Organization (CDSCO) and some state drug control agencies.
In continuation to the USFDA warning, Jubilant Life Sciences in its BSE Statement also mentioned:
“However, we believe that the existing manufacturing and sale of products from this facility will not be impacted. US revenues from the facility is about 4 per cent of the total revenues of the company,”
The statement had a clear indication of what the company wanted to mention to the market in terms of its business standing. The facility accounts for about 4 per cent of Jubilant’s total revenue. What’s interesting here is that the pharma giant said the this would not impact sale of products from the facility; but what about the impact on consumers?
It can be argued that a significant number of produced drugs from the Roorkee facility go into the Indian market as well as other lesser vigilant markets. Adulterated or counterfeit medicine finds its way into such markets much easily and seldom do wrongdoings on the part of the manufacturer come out.
In another blow to transparency in the critical sector, a new norm by Drug Controller General of India, passed a set of clinical trial rules that will fast-track proposal clearances for Indian companies rather than their multinational counterparts, though on the back of bureaucratic leverage rather than enforced transparency. Eswara Reddy of DCGI said:
“Indian companies will be provided incentive to start clinical trials and their proposals will be deemed approved in case they do not hear from the DCGI on the status of their application within 30 days,”
The Indian drug regulation agency has been perpetually plagued with lack of resources and manpower to keep such practices in check. This issue surfaced again in December last year, when a dire shortage of drug inspectors was reported to be adversely affecting the functioning of the State Drugs Control Department in Kerala. Report said that the state had a mere 47 drug inspectors to inspect more than 21,000 medical stores functioning in the state.
In a 2017 survey, conducted to check the proportion of substandard drugs in the country, CDSCO tested 47,012 samples from 1,719 manufacturing units and found around 3.16% of these samples to be not of standard quality, while 0.02% were spurious.
CDSCO has been sounding its horn to bring down the proportion of its substandard drugs to 2% over the next three years to match global standards. It has been engaged in risk-based inspections of over 250 manufacturing plants in the last couple of years. Discrepancies shall remain and miscreants will keep escaping enforcement’s claws till the point India’s level of testing standards and inspection manpower doesn’t reach the standards in the West.
- India is the world’s top drug producing destination due to low manufacturing costs
- USFDA has been pushing since 2016 to bring the Indian Drug Regulatory body up to the mark in its knowledge and practices
- Indian drug regulator CDSCO is desperately short in numbers which presents a tough ask to monitor the country’s growing drug manufacturing and supply facilities
- CDSCO has been sounding its horn to bring down the proportion of its substandard drugs to 2% over the next three years to match global standards.