The Union health ministry is in the process of finalizing amendments to reform The Drugs & Cosmetics Act 1940 , including a more centralised approach to licensing the manufacture, sale, and distribution of drugs, according to people familiar with the matter, in a move aimed at ensuring that India’s emerging role as a pharmacy to the world isn’t affected by a few companies deciding to flout quality norms or not adhering to good manufacturing practices (GMP).
The amendments include a centralised drugs database for effective surveillance across the country. If implemented, the move will help drugs regulators know the credentials of all pharmaceutical companies and drugs— newly approved or in use— at the click of a mouse. Currently, there is no common database to alert the national drugs regulator to concerns raised by a state drugs regulator.
“To assure better quality drugs, it was decided by the ministry to amend the archaic Drugs & Cosmetics Act. Health is a state subject but as part of the amendment, it has been decided that the central government will have to take control of certain powers to maintain quality of drugs being produced in the country,” said a senior government functionary, requesting anonymity.
“As part of the amendment , the government also plans to have a common drugs database. Currently, for lack of a central database, it is not easy to tell which drug has received an approval. There are certain gaps that need to be plugged in our regulatory system -- for instance, the inspection teams under state drugs controllers need to be strengthened. At the central level, squads have been created that go for inspection twice every week. So far, 25 companies have been issued closure notice for failing inspection,” added the official.
{{/usCountry}}“As part of the amendment , the government also plans to have a common drugs database. Currently, for lack of a central database, it is not easy to tell which drug has received an approval. There are certain gaps that need to be plugged in our regulatory system -- for instance, the inspection teams under state drugs controllers need to be strengthened. At the central level, squads have been created that go for inspection twice every week. So far, 25 companies have been issued closure notice for failing inspection,” added the official.
{{/usCountry}}According to the ‘action taken list by state licensing authorities’, accessed by HT, among the companies who had their manufacturing licences suspended or were directed to stop production included Himalaya Meditek Pvt Ltd registered in Dehradun, Sun AJ pharma, Indore (MP), Vintochem, Ujjain (MP), Om Biomedic, Haridwar (Uttarakhand), SVP Life Sciences, Dehradun, Uttarakhand, Apple Formulations, Roorkee, Uttarakhand, Relief Biotech, Roorkee, Uttarakhand, Agron Remedies, Kashipur, Uttarakhand, and Bajaj Formulations, Roorkee, Uttarakhand.
The current law is a pre-independence legislation and review of obsolete laws and updating of the existing laws is a continuing process to accommodate changed requirements and adaptation of new technology. The consensus regarding proposed amendments came after a brainstorming session in February that involved both central and state drugs regulators.
According to the people familiar with the matter, the deaths linked to India-made drugs in The Gambia, Uzbekistan, and the US, had a major role to play in conducting the camp. The brainstorming session had five modules on the key aspects of drugs manufacturing, sale, distribution and regulations in the country.
The first was on building trust and confidence in quality of India-made drugs, cosmetics, and medical devices in domestic and export markets. The second was on effective enforcement at the field level. The other three were conducted on the Indian pharmacopeia and adherence to its standards; a centralised database; and capacity building of state and national regulators.
“Various crucial inputs received during the session have been included in the proposed amendments that are on the verge of being finalised. It is our responsibility to ensure we produce quality drugs in the country and also maintain the quality of our exports as India has a reputation for being the pharmacy of the world, which needs to be maintained,”added the functionary cited above.