Sri Lanka blacklists Indian drug suppliers

Sri Lanka's Ministry of Health has blacklisted at least a dozen of Indian drug suppliers for violating tendering procedures and supplying low quality medicines, officials said.

Health Minister Maithripala Sirisena has directed his officials to look elsewhere for supplies to meet urgent requirements, officials added.

"I have been told by my officials that Indian companies have violated tender procedures or have supplied low quality drugs," Sirisena was quoted as saying in local press. The Indian companies' shortcomings have led to shortages in some urgently needed medicines, officials charge.

Around 100 Indian drugs suppliers are in the Colombo Health ministry's suppliers roll, but the companies in the spotlight have been blacklisted for supplying sub-standard medicine while paying no heed to deadlines for supply and violating procedures.

Maharashtra FDA detects 20 not-of-standard drugs in April

The Maharashtra Food and Drugs Administration (FDA) has detected 20 not-of-standard drugs during the month of April in the random sample testing. In April manufacturers from the tax-free state of Himachal Pradesh with 10 and Maharashtra with 5 not-of-standard drugs accounts for the major share.

Well-known drug manufacturers like ASA Biotech for Miscef-100, Athens Labs for RT-Zyme syrup, Ion Healthcare for Rabeprazole sodium tablets, Emcure Pharmaceuticals for Orofer XT suspension, Ciron Drugs & Pharmaceuticals for Co-Trimoxazole paediatric mixture IP/Co-Trimoxazol and Rhydburg Pharmaceuticals for Becoplex Forte also figure in the list.

Other highlights of Maha FDA's not-of-standard drugs list include - samples for not complying with IP requirements Atul Pharmaceuticals (Bethasone tablets), Affine Formulation (Prima 7.5 tablets/primaquine phosphate tablets), Ion Healthcare (Rabeprazole sodium tablets), Magbro Healthcare (Rabeprazole sodium tablets), Mission Laboratories (Healsera tablets), Prashi Pharma (Davithro 500/ Erythromycin stearate tablets).

Out of 20 such drug samples found in April, 10 were from Himachal Pradesh, five from Maharashtra, two from Gujarat and one each from Jammu and Kashmir, Uttaranchal and West Bengal.

During April other companies in the FDA list include: Atul Pharmaceuticals and S R Pharmaceuticals from Gujarat; Affine Formulation, ASA Biotech, Athens Labs, Elfin Drugs, Health Biotech, Ion Healthcare, Magbro Healthcare, Mission Laboratories, Orison Pharma International, Skyline Pharma from Himachal Pradesh, Emcure Pharmaceuticals from Jammu and Kashmir; Prashi Pharma, Snow Chem Industries, Zim Laboratories, Ciron Drugs and Pharmaceuticals from Maharashtra, Rhydburg Pharmaceuticals from Uttaranchal and C I Laboratories from West Bengal.

The state FDA routinely picks up random samples of drugs from chemists and druggists and sends for testing. The Department will soon issue show cause notices to these companies

Health minister of TN instructs Drug Control Dept to continue action against illicit drug traders

When Chennai and other parts of Tamil Nadu are flooded with expired drugs and illicit drug traders, the state health minister MRK Panneer Selvam reviewed the situation arising out of the recent raids and seizures of huge quantity of expired drugs by police and drug control officials from several parts of the state.In the review meeting called by the health minister in his office, besides the principal health secretary, it was attended by the director of Drugs Control Administration and other senior officers of the department.

According to sources, the minister was busy with the Pennagaram by-election, hence he could not comment so much on the present illicit drug trade in the state. Sources said the Minister has given strict instructions to the health department officials, especially to the drugs control director, M Bhaskaran to act properly and take immediate action on the illicit traders.

Whistleblower scheme for fake drugs gets takers

The whistleblower scheme introduced by the Ministry of Health and Family Welfare has kick started with the Government getting tip-offs on about 15 cases of fake drugs. The Ministry had introduced the scheme in December 2009 in a bid to put an end to the menace of spurious drugs being sold in the market. According to the reward scheme, whistleblowers would get as much as Rs 25 lakh or 20 per cent of the value of the confiscated fake drugs.

The scheme is being implemented by the Drugs Controller General (India). Health Ministry sources said that the drug regulator is investigating the cases already reported and if the drugs seized during raids are found to be fake then the informer would be given a reward.
Similar reward schemes have been put in place by other Government agencies, including informers of income-tax evasion and illegal imports.

According to Government estimates 0.046 per cent of all medicines sold to customers are spurious. But an earlier survey of 10,000 samples, funded by the World Health Organisation and undertaken by the International Pharmaceutical Federation, had concluded that 3.1 per cent of drugs in India were counterfeit.

The Government had recently tightened laws for punishing offenders caught with spurious drugs. The amended law enhances the penalty for manufacturing spurious drugs to a minimum imprisonment of 10 years

Reward Scheme for whistleblowers in the fight against the menace of spurious or fake drugs, cosmetics and medical devices

Central Government has devised a scheme for giving monetary rewards to the whistleblowers who can take risk of providing the information about the perpetrators of such crime. Such scheme is already operational in other enforcement departments of Government which pays good dividend also in terms of voluminous catches / seizures. The Reward scheme provides for giving handsome rewards to the informers who provide specific information to the designated authorities leading to the seizures of spurious, adulterated, misbranded and not of standard quality drugs, cosmetics and medical devices. This reward scheme will be applicable to both the informers as well as the officers of the CDSCO. In the fight against the menace of spurious or fake drugs, cost of such social participation will be minimal given the proportion of damage inflicted by the perpetrators of the crime on the health of the society and the economic progress of the country.

The salient features of the aforesaid reward scheme are as follows:-
(i) The reward scheme shall be applicable for whistleblowers in the area of drugs, cosmetics and medical devices.

(ii) Reward is to be given to the whistleblowers i.e. the informers / officials only when there is a confirmation of the seizure of spurious, adulterated and misbranded drugs, cosmetics and medical devices by the designated officers of the CDSCO.

(iii) The reward of maximum of upto 20% of the total cost of consignments seized will be payable to the informer / officials which should not in any case exceed Rs 25 Lakh in each case.

(iv) In respect of an officer of the Government / CDSCO, the reward should not in any case exceed Rs 5 Lakh for one case and a maximum of Rs 30 Lakh in his / her entire service.

(v) With a view to ensure that the informers are not made to wait till the final disposal of the matter, 25% of the amount will be given at the time of filing of the charge sheet in the court of Law.

(vi) Further, with a view to ensure that the informers do not turn hostile during the trial of the case and continue to assist the court in deciding the matter in favour of the Government, 25% of the amount will be given to them at the time of disposal of the case in favour of the Government in the first court of law.

(vii) The remaining 50% amount will be paid only when the case has been finally disposed of in favour of the Government and no appeal with respect to the matter is pending in any other Court of Law in the country.