The Central Drugs Standard Control Organisation (CDSCO) is appointing two external consultants as part of its drug regulatory rationalisation initiative, the Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said. One of them is set to start in July.

The consultants would look at CDSCO’s internal processes besides redundancies in external-facing regulatory framework, including the Drugs and Cosmetics Act, Raghuvanshi said. One of the consultants has been appointed, he told media-persons, without divulging names. Besides this, another 250 people are to be recruited to strengthen the regulatory infrastructure, he added.  

July will also see audits start on pharmaceutical manufacturing units of companies with revenues of over ₹250 crore, he said, referring to the revised Schedule M norms that involve good manufacturing practices (GMP). Of the 10,000-odd manufacturing units, 80 percent were in the micro, small and medium enterprises (MSME) segment, he said.

Big ticket initiatives

Raghuvanshi and Arunish Chawla, Secretary, Department of Pharmaceuticals, outlined the slew of measures undertaken by the Centre to strengthen the quality culture of the pharmaceutical industry. They were speaking at the Global Pharmaceutical Quality Summit, organised by the Indian Pharmaceutical Alliance.

Other “big ticket” initiatives expected from the CDSCO included a unified drug regulatory platform for government and private organisations in the value chain that would give an overview of developments, Raghuvanshi said. Efforts were also underway to develop a scientific cadre to undertake scientific reviews internally and bring in consistency, he explained.

In the last 15 months, about 400 manufacturing units were inspected and 36 percent had to be closed, he said.

Later, he told the media that about 10 percent of those closed, did so permanently.  A combination of the measures taken by the Centre had resulted in no complaints being received from global markets in several months, he said. The last few years had seen contaminated cough syrup and eye-drop-related incidents link back to some domestic pharma companies.   

On measures taken internally, Raghuvanshi said, 207 routine transfers had been undertaken in the CDSCO — a first of sorts. Departmental enquiries had been initiated on those involved in malpractices, he said, and some were terminated. Internal quality assurance teams were also undertaking audits at sea and airports to improve operations, he added.

Funding support  

To meet the upgraded Schedule M standards, Arunish Chawla said, the revised Pharmaceuticals Technology Upgradation Assistance would approve its first tranche of funds to MSME applicant in about a week. GMP will be mandatory for public procurement, including for Jan Aushadhi, he said. (Jan Aushadhi is the Centre’s network that sells medicines at low prices). Giving details on the PLI (production linked incentive) schemes, he pointed to the opportunities opening up in five years, with 300 molecules going off the patent cliff.  Indian companies were ready for this he said, adding that they were already breaking stereotypes, including exporting more bulk drugs, for example.