Drug export regime recast to soothe quality concerns

The drug regulator will upgrade India’s Certificate of Pharmaceutical Product (CoPP) to match the World Health Organization’s good manufacturing practices certification as part of an overhaul of the export approvals process, two officials familiar with the development said.

The CoPP and the WHO’s certificate are the preliminary documents required for obtaining product approval and market authorization for exporting pharmaceutical items from India. The move will also help foreign regulators ascertain the authenticity of Indian drugmakers.

“The plan is to put these certificates on the website of the CDSCO so that importing countries or regulators can check whether these certificates are issued by CDSCO or not,” one of the two people cited above said.

The idea is to bring in transparency in the system, including greater oversight over the number of products shipped by Indian companies and their quality, the official said on condition of anonymity.

India’s Central Drugs Standard Control Organisation is the apex regulatory authority for the pharmaceuticals, medical devices, and cosmetics industries, similar to the US’s Food and Drug Administration. The Drugs Controller General of India, or the DCGI, operates under the CDSCO.

Under the new guidelines, state governments can issue CoPP certificates to pharmaceutical companies only if CDSCO officials are involved in joint inspections.

To ensure that Indian pharmaceutical companies are manufacturing quality products, the DCGI has directed companies to strictly adhere to the WHO’s good manufacturing practices guidelines at their production facilities.

As part of the overhaul, theUnion government recently wrested authority from states to become the sole entity responsible for issuing manufacturing licences for drugs meant for exports.

A health ministry spokesperson did not immediately reply toMint’squeries on the developments.

Safety and quality concerns

India is the world’s largest exporter of generic medicines, which are authorized copies of patented drugs. In 2022-23, India exported pharmaceutical products worth $25.4 billion to about 210 countries. Around 60% of the country’s pharmaceutical exports go to highly regulated markets such as Europe and the US, India’s largest market.

But drugs manufactured in India have regularly been seized by global regulators primarily over safety and quality concerns.

In August, theWHO raised an alert over a batch of contaminated cough syrup found in Iraq and manufactured by Fourrts (India) Laboratories Pvt. Ltd. WHO said both the manufacturer and the marketer, Dabilife Pharma Pvt. Ltd, India, had failed to provide guarantees on the safety and quality of the product.

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Cough syrups made in India have been linked to the deaths of dozens of children in Uzbekistan and Gambia, which prompted the Indian government last year to make it mandatory for these medicines to be tested before exporting them.

Before the WHO’s warning, in April last year, the DCGI cancelled or suspended the licences of 18 pharmaceutical companies for allegedly producing spurious or substandard drugs.

The move to bring uniformity in the CoPP and the WHO’s certificates is welcome as it will bring confidence to exporters and overseas regulatory bodies that exports from India are of high quality and under the supervision of the central government, said Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance.

Strengthening exports

Amid heightened global concerns about pharmaceuticals made in India, the government’s efforts, along with India’s Pharmaceutical Export Promotion Council, or Pharmexcil, are also directed at strengthening the country’s drug exports.

Because of a lack of uniformity in the CoPP and the WHO’s good manufacturing practices certificate format, foreign drug regulatory agencies find it difficult to validate the authenticity of Indian pharmaceutical companies, said a second person familiar with the recent developments.

Overseas regulators such as the Drug Administration of Vietnam are writing to their embassies to verify these companies. The plan now is to unify and centralise issuance of the certificate, this official said, declining to be identified.

Another issue under consideration is on whether to allow manufacturers to supply and divert un-exported quantities of pharmaceutical items to other countries with the approval of the CDSCO and subsequent licences from overseas regulators.

“There are a few issues which need to be resolved to strengthen the pharma exports,” said the official.

“For example, if permission has been given for an export of 1,000 kg of pharma items to a party importing from some country, and if the importer cancels the order or if he consumes only 500 kg, the remaining 500 kg we need to destroy,” said the official.

“Now, the plan is that this exporter can supply the remaining pharmaceutical goods to some other party with prior approval from DCGI and regulatory authorities of the other country. Therefore, a provision is being made to amend the (no-objection certificate) conditions of physical destruction of all un-exported quantity of the drugs.”

A recent communication from Pharmexcil to CDSCO thatMint has seen addresses this issue.

“The excess quantity manufactured under Test License and un-exported, needs to be destroyed by the manufacturer as per NOC conditions, which leads to great economic loss to the industry. This is mostly happening in potent molecules and high value products such as anti-cancers and biotech derived products etc,” states the communication.

“It is requested that necessary changes and amendments in the conditions of NOC may be made, permitting the manufacturer to supply or divert the un-exported goods to another importer with the prior approval from CDSCO and subsequent license from concerned FDA,” it added.

Wastage in pharma exports is a huge loss to the country as well as the exporters, said Daara B. Patel, secretary general at the Indian Drugs Manufacturers Association. “We don’t have any problem in exporting remaining pharma products to another party.”