Protecting India's Image As The 'Pharmacy Of The World'

The government was stern but polite with its message that pharma companies need to be more vigilant and stringent about their product quality.

“The recent incidents related to Indian medicines worldwide fetched a bad name. Taking cognisance of it, the Government of India has taken several measures, including necessary certification for medicine exporters for selected countries,’’ said Pharma Secretary Arunish Chawla.

“We have also taken actions against substandard and spurious drugmakers. A large number of pharma companies were forced to close down operations. As we found that they were not adhering to our set standards, we came up with stricter measures, including monitoring,” he added.

Pharmacy Of The World

The Indian pharmaceutical industry was widely hailed for its cheap generic medicines. That was before 2023, when reports of deaths and adverse effects caused by sub-standard Indian medicines in Uzbekistan, Gambia, Cameroon and Colombia, began to flood in. 

Reports say the consumption of a cough syrup made in India led to the death of 68 children in Uzbekistan from December 2022 to January 2023. Earlier in July 2022, 70 Gambian children died of acute kidney failure after consuming another India-made cough syrup.

In October 2022, the World Health Organisation (WHO) issued an alert that four cough syrups sold in Gambia by India-based Maiden Pharmaceuticals Ltd were of substandard quality, and claimed they were linked to the death of many children there.

In July 2023, an international news agency reported: “Hospitals around the world use drugs from a small but crucial Indian supplier. In Colombia, four children died and more than a hundred fell ill.” The report named Mumbai-based Naprod Life Sciences as the company that produced Methotrexate, which is used to treat cancer.

“Methotrexate, a drug used to treat leukaemia and other cancers, is commonly prescribed, usually tolerated, often given as an injection. Much of it is manufactured in India,” the report said.

The Indian Drugs Manufacturers Association president Viranchi Shah told The Secretariat, “Indian pharma companies have received a bad reputation, especially in the last few years, which is unfortunate. Substandard drugs are not dangerous for overseas customers alone, they can also kill our own people. The Indian government needs to ensure that quality of medicines is maintained at all costs."

Government Cracks Down On Errant Units

Already in December 2023, state and Central drug regulators had inspected 76 pharmaceutical companies, at the end of which the DCGI revoked licences of 18 companies accused of producing spurious drugs.

The government also cracked down on 50 companies that were not following standards in manufacturing cough syrups. Paracetamol 500 mg, Telmisartan (an anti-hypertension drug), Cuftin (cough syrup), Clonazepam tablets (used to manage seizures), Diclofenac (for pain relief), multivitamins and calcium tablets were among the 50 products under the scanner for being sub-standard.

Then in February, the Drugs Controller General of India (DCGI) instructed all units in states and Union Territories to keep strong vigilance and maintain surveillance on the quality of drugs available in the market with random sampling.

The government has also directed state drug regulators analyse cough syrups meant for export. The Directorate General of Foreign Trade has mandated the testing of cough syrup samples and the production of a certificate of analysis before export, as quality assurance for pharmaceutical products leaving India.

However in October, the government exempted manufacturers from having the necessary certificate to export cough syrup to the UK, the US and Japan, provided the regulators of the respective countries allowed them.

More Needs To Be Done To Stay Vigilant 

Until December 2023, India didn’t have laws to recall substandard medicines from the market. But after much hue and cry, the government in December 2023, introduced a provision, which empowers the government to recall defective or adulterated medicines even if they have hit the market.

The WHO defines substandard drugs as medicines produced by authorised manufacturers that do not meet quality specifications set for them by the national authority.

Counterfeit drugs, on the other hand, are defined by the WHO as medicines deliberately and fraudulently mislabelled with respect to identity and/or source.

The WHO holds that both branded and generic products may be counterfeited.

It says, “Counterfeit medicines may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging."

The new mandate is part of the changes in the Drugs and Cosmetics Rules, 1945, notified by the Union Health Ministry for adhering to good manufacturing practices (GMP) in the pharma sector.

Changes in Schedule M of the Rules, which deals with GMP requirements for pharma manufacturers, were notified on December 28.

Experts, though, say these provisions may not be sufficient to address all concerns. “The existing provisions are inadequate,” said Dr Sushil Munjal, senior chest specialist, National Institute Of Tuberculosis and Respiratory Diseases, Delhi. 

India Pharma Exports On The Rise

Exports of Indian pharmaceuticals is projected to reach US$ 55 billion by 2030. Over the last six years, pharma exports have grown from US$ 18.75 billion to US$ 27.85 billion (2023-24) with a CAGR of 8.25 per cent.

Indian pharma exports  which stood at about US $ 27.9 billion in 2023-24 is expected to rise ro US $ 29  billion this financial year, according to pharma association Pharmexcil.

The global pharmaceutical market was valued at US$ 1.49 Trillion in 2023. Of the global generic market of US$ 482 billion in 2023, Indian pharma contributed US$ 53 billion.

The Indian pharma industry is already facing challenges due to geo-political turbulence, and from importing countries localising manufacture of pharmaceuticals as part of a push towards self-reliance.

The challenges posed by bad reputation can only be beaten back when the government assures better drug quality via checks and penalties, including suspension of licences of defaulting companies.

Only such decisive and stringent measures can repair India’s reputation as the ‘pharmacy of the world'.