DCGI Streamlines Drug Export Approvals & Strengthens Oversight

In an initiative intended to streamline the export of drugs and improve productivity, the Drugs Controller General of India (DCGI) has made significant changes in the way No Objection Certificates (NOCs) are issued for unapproved drugs exports.

Previously, Indian exporters had to obtain separate NOCs for each order they received, which were issued based on the client’s identity and drug quantity. Now, under the newly modified procedure, DCGI will issue a one-time NOC for orders fulfilled during the previous year which is contingent the drug is included on the positive list of the importing country. The NOCs will be non-specific to clients or importers and instead granted based on the specific product and the relevant country alongside the issued region. This change will lower the number of issued NOCs to around 5,000 from almost 15,000.

This change will in practice alleviate a great deal of the regulatory strain put on the exporters.

During his comments on the Global Pharmaceutical Quality Summit, Rajeev Raghuvanshi, the DCGI, shared the following: “We are making compliance easier. Companies now only need to give proof of regulatory approval and provide details about their clients once every year instead of submitting them on multiple occasions.” 

This action is likely to greatly improve the efficiency of including exports and still retain necessary regulations. 

The DCGI has also stated that his office will issue revised guidelines for biosimilars in the near future. This will be the first update since 2018, and the new update will aim to put Indian rules on par with the latest developments in the rest of the world. Moreover, the Central Drugs Standard Control Organisation (CDSCO) is also working on its first set of regulatory guidelines for cell and gene therapy which is currently under the jurisdiction of the Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR). 

As Raghuvanshi said, “We are working on making sure that there are processes to clearly outline approvals for cell and gene therapies while ensuring that these processes are in line with international best practices.”

The CDSCO has expanded its inspections, carrying out almost 905 inspections in the last two years alone. After the Aveo incident, it became necessary for the agency to supervise the companies that were given NOC to check their adherence.

In explaining why India needs to provide more help in the export markets regulatory gaps, and especially for low and middle income countries (LMIC), he said, “A lot of LMICs depend on the regulatory systems of the country that exports.” He continued, “We need to make sure we have a robust system to enable them.”

Further, Raghuvanshi presented the status of the all-inclusive digital regulatory platform project, which has a budget of 100 crores, a flagship initiative of integrating all the regulatory stakeholders. He explained, “This platform will integrate the state regulators, partnered bodies like customs and GST, and the manufacturers into one single platform, enabling creation of a central database that contains information on entire regulatory value chain.” The platform intends to integrate the information from the first approvals to the last sales in the chain managing the supply and will be in service in two years.

Raghuvanshi has also pointed out the issue of internal scientific capacity development within the CDSCO. “We are in the process of creating new positions for evaluators and reviewers,” he mentioned. “Our current personnel are largely trained to implement the law, not to undertake scientific assessment at such depth.” This is an attempt to lessen the dependence on SECs for all technical tasks. 

Raghuvanshi also provided insight into the CDSCO’s position regarding SEC meetings and said that re-deliberations will be allowed but only on the basis of new evidence provided by a company. “We will not allow companies to push the same materials to SECs,” he clarified. 

He also volunteered that adjustments to the test licences regarding small imports for test and analysis are potential changes with more information to be provided in subsequent rules. 

The announcements from the DGCI give attestation to the coordinated effort to enhance and strengthen India’s drug regulatory framework to ensure safety internally and responsible exports. 

INSET 

The DCGI is reconsidering the NOCs that were previously allocated to Aveo Pharma. 

The DCGI stated it is reviewing the NOCs issued to Aveo Pharmaceuticals, a pharma exporter accused of shipping a cocktail of the unapproved drugs tapentadol and carisoprodol. Other companies with similar products may come under scrutiny as well.

The company was previously granted 77 NOCs by the authority and all of them have now been cancelled. The DCGI is assessing the documents that the company submitted to the regulator for NOC clearance.

This step came against Aveo Pharma after the recent investigation conducted by BBC, which brought to notice a scandal wherein an Aveo Pharmaceuticals a Mumbai based producer was supplying the unlicensed concoction to several West African nations including Nigeria, Ghana and Côte d'Ivoire.

The Union Health Ministry stated that upon comprehensive audit, Aveo Pharmaceuticals has been given a Stop Activity Order meaning all activities at the locations of the company and it’s premises are shut down with immediate effect by a joint committee of CDSCO and state regulatory authority of Maharashtra.

After the audit, the raw materials, in-process materials and finished goods of all items were seized by the investigation team.