Drug regulator DGCI is conducting a “focussed scrutiny” of medicines sold by Ranbaxy and some other drug makers, but says it remains confident of the quality standards of Indian medicines despite concerns raised by US authorities over some of Ranbaxy’s products.
While the company continues to assert that its drugs meet all regulatory standards, a few hospitals and pharmacies have adopted a cautious stand on use of its products.
However, a majority of hospitals and chemist chains continue to pose faith in Ranbaxy drugs, pending any adverse direction from the authorities concerned.
Mumbai-based Jaslok Hospital recently asked its doctors to stop prescribing Ranbaxy products, while country-wide chemist chain Apollo Pharmacy has announced taking a cautious stance on Ranbaxy drugs without stopping the sales.
Asked about the concerns being raised over Ranbaxy products in the wake of orders passed against the company by the US Food and Drug Administration (FDA), DCGI G.N. Singh told PTI that no Indian company is selling sub-standard drugs and it is conducting a scrutiny to reconfirm this view.
Questions have been raised over drugs supplied by Ranbaxy after the company pleaded guilty to “felony charges” in the US and agreed to pay USD 500 million in penalty last month for violation of approved drug manufacturing standards at its two plants in India.
“We are sure that drugs being used in the country are safe, efficacious and of the quality. But in light of the recent reports, we have initiated the exercise only to reconfirm the standards,” Mr. Singh said.
“Since we have put our regulatory mechanism on fast track, not only Ranbaxy but some other companies would also come under focused scrutiny,” he added.
“Any company found guilty of wrongdoing would be punished according to the existing provision of the relevant laws”, Mr. Singh said, while adding that the report based on the findings would be submitted to the government within a month.
Most of the major hospitals and pharmacies across the country said they would wait for a word from DCGI and other authorities before any decision against Ranbaxy products.
Mumbai-based Hinduja Hospital’s Director (Professional Services) Gustad Daver said that the hospital would not issue any advisory against Ranbaxy drugs, unless told to do so by the regulatory authority.
A spokesperson for Ranbaxy said that the company has also started receiving orders from Jaslok Hospital, which had earlier issued an advisory against the company’s drugs.
Officials at some other leading hospitals in Mumbai, including Kokilaben Hospital, KEM Hospital, Nanavati and Bombay Hospital said they continue to prescribe Ranbaxy drugs.
Elsewhere, a top official at Fortis Healthcare in Chennai said the hospital has not got any directive from the Medical Council of India or any government authority in this regard and they would take a decision as per their directive.
Chennai-based V Mohan Diabetes Centre on the other hand said they were anyway using very few of Ranbaxy drugs and a decision for blanket ban was unlikely as of now.
A senior official in the Tamil Nadu State Health Department said the state would follow the directive if the DCGI advises against use of Ranbaxy drugs.
Chennai-based SRMC hospital also said its has not issued any advisory against Ranbaxy drugs and it would wait for directions from the concerned regulatory authorities.
Ranbaxy, on its part, said that they have touched base with Apollo Pharmacies, Jaslok and other hospitals and they are satisfied with the company’s response. A spokesperson for Ranbaxy also added that Gurgaon-based Medanta hospital also continues to supply and prescribe the company’s medicines.
Hyderabad-based Yashoda Hospital’s Chief Operating Officer R. Chandrasekhar said the group has a committee that decides on procurement of medicines and the issue of Ranbaxy drugs has not figured in its discussions so far.
A senior official of Hetero Pharmacy, which runs retail drug stores across Andhra Pradesh, said they continue to sell Ranbaxy medicines as there was no caution or complaint as yet.
DCGI G.N. Singh said it is for the regulatory authorities to decide whether any medicine meets quality standards or not.
Mr. Singh said that the Central Drug Standards and Control Organization (CDSCO) has a very robust system of issuing drug alerts to prevent sale of any substandard drug in the market.
“If any drug is found to be not of standard quality, CDSCO sends alerts on monthly basis on its website to enable the patient and the regulator to recall those medicines from the market, if required”, he added.
Asked about the action taken by the authorities after the issue of Ranbaxy came to light, Mr. Singh said that the decision to conduct a scrutiny was taken to “reconfirm” the quality of drugs being marketed and manufactured in the country.
He, however, simultaneously claimed that drugs used in India are not sub-standard.