Earlier this month, India’s apex drug regulator formed a 7-member panel to prepare the country's first-ever National Drugs Database, saying that such a registry would empower consumers and improve the mechanism to monitor the quality of drugs in circulation.
The development comes amid doubts being raised over whether contaminated cough syrups made by Haryana-based Maiden Pharmaceuticals led to the deaths of nearly 70 children in The Gambia, as indicated by the World Health Organization in September.
Following the WHO alert, Indian authorities had raided Maiden Pharma’s units in Sonepat and had ordered the suspension of all production there after finding glaring good manufacturing practice violations.
However, the Indian government’s demand for the causal assessment report, to ascertain if the children died because they consumed the allegedly spurious drugs — has not been met yet by the WHO. Authorities in The Gambia, too, have raised questions over the deaths, saying that all of them may not have occurred due to the contaminated medicine.
But sources in the Central Drugs Standard Control Organisation say that internal discussions, held in the aftermath of the tragedy, led to the recognition that there was poor quality control of drugs manufactured in a large number of units due to slack supervision by state drug administrations.
The new committee, formed under the chairmanship of a joint Drug Controller General of India, has now been tasked with preparing a database on drugs. It will include information such as their dosage, form, strength, details of the manufacturer, marketer and importer.
“While we do have details of manufacturing units licensed in India — there is no central repository related to all the drugs produced or sold in the country,” said a CDSCO official. “We hope that the new database will aid (in establishing) a uniform drug regulatory system in the country.”
Will it help?
The announcement has raised hopes that India will soon have a stronger drug quality regime but experts say that it is not clear how exactly the move will help quality and that it may depend on details accumulated through the database.
Pharmaceutical expert Chinu Srinivasan, who is with patient rights group All India Drug Action Network, said that the database should at least have information such as the contents, strength and indications for every drug.
“There is no source of information currently to understand how many rational and irrational medicines are approved and their brand names, if any,” he pointed out. “If the database is accurate, we will have details related to approvals of medicines, too. I feel that it may not improve quality but will at least improve rationality”.
Clinical pharmacologist and bioethicist Dr Urmila Thatte, who was previously with KEM Hospital in Mumbai, added that after initial approval for a new drug centrally, the drug marketing license is issued at the state level, and there is no record of this maintained at the central level.
“So we really have no data about drugs being sold in the country, such as generics, a few years after a drug is introduced,” she said. “Let’s hope that we can now keep a track of the drugs produced and marketed in India.”
Uniform administration
Industry representatives meanwhile said that the proposed database is an encouraging step that will result in strengthening regulatory systems to monitor quality.
“After the drug formulations are provided through this database, control over quality will become stringent, which means manufacturing and marketing of drugs will be watched closely,” said Raheel Shah, Director, BDR Pharmaceuticals. “This move will earn us various forms of recognition around the world as well.”
“After the US Food and Drug administration, European and Australian good manufacturing practices, India, too, will be moving towards a uniform administration.”
The network of multinational pharmaceutical companies in the country said that it supports the government’s initiative in strengthening access to safe drugs and understands that the database is an endeavour to keep patient safety at the core.
“This comprehensive database is an appropriate step in ensuring transparency, amplifying access, and increasing knowledge about the drug’s quality and efficacy among patients and healthcare professionals,” said Vivek Sehgal, Director General, Organisation of Pharmaceutical Producers of India.
Credible information on manufacturers, drugs and dosage will strengthen the monitoring procedure and safeguard the quality and effectiveness of the drugs, he said.
In addition to empowering patients, Sehgal said such a database would improve the mechanism to monitor the quality of drugs being dispensed across the country, and ensure that manufacturers adhere to ethical business practices.
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