The Ministry of Health should consider amending the Drugs and Cosmetics Act (1940) and instituting a centralised drugs database to enable effective surveillance across all pharmaceutical manufacturers. (Express Photo)
It must move from being a manufacturer of generic drugs to becoming one associated with quality generic/innovative drugs
Written by Feroze Varun Gandhi
May 18, 2023 07:15 IST
In January 2020, 12 children in Jammu died after consuming contaminated medicine manufactured by Digital Vision, a firm in Himachal Pradesh. The medicine was found to contain diethylene glycol, which led to kidney poisoning. Digital Vision’s products had been red-flagged on 19 occasions by various state and central drug laboratories. After the incident, Himachal’s state regulator found quality control failures in its site inspection of the manufacturer’s facilities. Yet, six months later, a two-year-old from Himachal Pradesh died after consuming Cofset cough syrup, another product manufactured by Digital Vision.
In March 2021, another product, Nycup syrup, was found to have lower levels of the active ingredient by testing agencies. But regulatory action was limited, with the regulator finding it challenging to build a case against the manufacturer. India has close to 36 drug regulators. Yet, such incidents continue to happen.
India is proud of its pharmaceuticals industry. India is the largest manufacturer of generic medicines globally and its exports impact the lives of the global poor daily. The rise of this industry was not easy — entrepreneurs struggled to achieve scale, while being hampered by regulations in many export markets and defamatory tales of how Indian drugs are ineffective or worse, harmful. The industry is one of India’s true success stories — one of the few examples of competitive manufacturing. However, quality concerns persist — recently, 48 drugs have failed to meet quality standards. Three per cent of all drugs in routine use — for hypertension, allergies and bacterial infections — were found to be substandard by regulatory inspectors.
In February, Global Pharma Healthcare, a Tamil Nadu-based firm, was forced to recall an entire batch of eye drops exported to the US after it was linked to vision loss. Cough syrups made in India by Maiden Pharmaceuticals and Marion Biotech were linked to the death of children in Gambia and Uzbekistan respectively in 2022. The country’s drug regulator, however, maintained that its checks showed no toxic substances.
It is heartening that the Centre is taking steps to improve drug quality, with the cancellation of manufacturing licenses of 18 pharma companies after inspections across 20 states by the Drugs Controller General of India (DGCI). However, much more needs to be done.
Global regulators are catching on. Between November 20119 and November 2022, the US FDA raised 60 Official Action Indications (OAIs) — a mark of unsuccessful compliance with the US FDA regulations. Some OAIs have been escalated to import alerts, barring select firms from supplying drugs to the US market. Observations from select FDA on-site inspections at facilities (manufacturing cancer and insulin drugs) of large pharmaceutical players are concerning — procedures to prevent microbiological contamination of drugs were not established or followed through, environmental monitoring programmes do not include measures to control fungal contamination and deviations from established quality best practices have been highlighted. Such observations can undermine the reputation of India as a quality drug manufacturing country.
The Ministry of Health should consider amending the Drugs and Cosmetics Act (1940) and instituting a centralised drugs database to enable effective surveillance across all pharmaceutical manufacturers. If Centre-state cooperation allows it, India’s 36 regional regulators can be consolidated into a single regulator, reducing the risk of regulatory capture via state-level patronage and influence networks. There should be common standards across states.
India has more than 10,000 pharmaceutical manufacturing units, 2,000 of which have been certified under WHO’s Good Manufacturing Practice Standards. Such units are owned by over 3,000 firms. Regulating them means a significant inspection load. Additional budgetary support is clearly required to strengthen inspection teams under state drug controllers and to enable a higher frequency of quality-related inspections.
The regulator, along with the industry, will have to make India’s drug regulatory regime more transparent and credible — in line with global standards and verifiable. At the very least, reviews of drug applications (ongoing/historical), along with detailed notes should be made public — similar to what the FDA and EMA do. We also need a public database listing past violations, inspection records and failure history of key molecules, brands and manufacturers.
Reports from all drug testing laboratories can be consolidated and made public. Greater centralisation of drug licensing and inspection is also a must. Safety data should be made public and clear penalties, including victim compensation, should be stipulated for firms exporting spurious drugs to international agencies. We also need a clear push for a national law on drug recall — this has been hanging fire since 1976.
Statutory backing must be given to the Central Drugs Standard Control Organisation (CDSCO) — the existing antiquated setup, where the Drugs Controller General of India is a low-ranked officer, has to be changed. A bill, similar to the Drugs and Cosmetics (Amendment) Bill, 2013 to create a Central Drugs Authority as an independent body must be framed and passed. India’s regulatory standards must be enhanced — future approvals of fixed-dose combinations must be scrutinised. Drug regulation must serve public health, instead of being a promoter of Indian drugs.
Beyond regulatory action, the industry must also step up. It must move from being a manufacturer of generic drugs to becoming one associated with quality generic/innovative drugs. Despite adverse media coverage, countries like Ecuador, Panama and Nigeria have recently sought greater access to Indian generics. The government has often spoken about making in India while embracing zero defect — India’s drug industry must step up to the challenge and deliver.
The writer is a BJP MP
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