Hyderabad: Drugs of 9 pharmaceutical companies were found to be substandard and have been blacklisted by the Andhra Pradesh Medical Services and Infrastructure Development Corporation ( APMSIDC) .

The following drugs meant for common ailments have failed the quality test. They are 

Karnataka Antibiotics and Pharmaceuticals Ltd
Injection Verclov 1.2gm (Amoxycillin+Clavulanic Acid), Batch no. 3401410

* Cipco Pharmaceuticals
Tablet Dicyclomine HCL 10mg, Batch No. CT-91201

* Hindustan Pharmaceu-ticals
Etophylline and Theophylline injection, Batch No. 426

* Vital Health Care (P) Ltd.
Prednisolone Acetate Opthalmic Suspension USP Batch No. V9094

* Jackson Laboratories (P) Ltd.
Pentasol Injection, Batch No. I.P.B NO.1-3236

* Bengal Chemicals
Ciprofolxacin Tablet 250mg, Batch No. 0578002

* The Swastik Pharmaceuticals
Povidone Iodine Solution, Batch No. 2667

* Eurokem Laboratories (P) Ltd.
Nifidifine Tablet I.P 10mg Batch No. F62

* Agron Remedies (P) Ltd.
Diclofenac Sodium Tablet, Batch No. DDF-35

SOURCE: DECCAN CHRONICLE

Judge Nityanand Singh of a CBI Special Court has remanded two medical suppliers to a couple of weeks judicial custody in a case relating to alleged irregularities in the purchase of medicines and medical equipment. The supposed scam, which  made the headlines in 2009, is believed to have  resulted in  an estimated 130 crore rupees loss to the State exchequer. The irregularities alleged in the case are believed to have occurred under the watch of the Madhu Koda regime in Jharkhand. Of the persons charge sheeted,three had been earlier remanded to judicial custody -  former health minister, Bhanu Pratap Sahi, and ex-health secretaries Pradeep Kumar and Siyaram Prasad. All of these five accused had surrendered before the court. Three persons were earlier given bail, and four are absconding.

SOURCE: IBN

Alarmed by reports of a flourishing spurious drugs market in Kashmir, world-renowned cardio-thoracic surgeon Dr Naresh Trehan urged governmental action while addressing a school function in Srinagar. Echoing Dr. Trehan’s alarm, Dr. Surinder Bazaz, a cardiologist who also participated in the function, said on the occasion that Kashmir had become “ … a den of spurious and substandard drugs”. The importance of a healthy life style was another issue that was underscored, with Dr.  Trehan counseling proper diet and exercise as a way  of keeping heart ailments at bay. Dr. Trehan went on to add that  Medanta,  a Delhi based multi-specialty hospital, was preparing to set up a facility in Kashmir in the coming months.

SOURCE: Greater Kashmir

Eleven persons contracted meningitis in three government run hospitals in Mumbai after being administered Bupivacaine, according to a report in Mid Day. Reacting to the story, the Food and Drug Administration undertook an inspection of the manufacturing plant of Ciron Pharmaceuticals, from where the hospitals received the drug.

Doctors at the hospitals said had reservations about administering the anesthetic and did so against their better judgment, they claimed. They claimed they had received a notification from a higher authority asking them to dispense the drug from hospital stocks instead of procuring them from pharmacies elsewhere.

The story goes back further, to two cases of meningitis in Sion hospital, suspected to be linked to Bupivacaine. Doctors alerted the FDA, which tested the drug and gave it a clean chit. However, following this, Sion, Bhabha and KEM hospitals reported cases of post spinal meningitis. In the light of such a  development, the use of the drug should have been immediately stopped, notwithstanding the clean chit from the FDA,  doctors interviewed opined.

In addition to its investigation of Ciron Pharmaceuticals, the FDA is collecting samples of Bupivacaine from the concerned hospitals for testing. K. B. Shende, joint commissioner, FDA (drugs), said a fresh enquiry has begun to investigate “… all possible causes of infection as well as contamination."

SOURCE: MidDay

While the moves to strengthen the regulatory mechanism a welcome one, there is a need also to deal with the promotional and publicity campaigns of drug manufacturers, by which doctors and pharmacists are incentivized to prescribe and dispense irrational formulations, the Planning Commission study also notes (Sinha 2011a). The DCGI has taken serious note of the issue of deceptive advertising. It has drawn the attention of  the state drug controllers and representatives of the Indian Medical Association (IMA) to take deliberate action upon the  "serious menace” of deceptive advertising in the  forthcoming Drug Consultative Committee (DCI) meeting scheduled for November 14, 2011. That the DGCI’s apprehensions are well founded is suggested by an investigation carried out by the National Institute of Pharmaceutical Education and Research, which found deceptive advertising to be a major concern. A report on that investigation, published recently in the Indian Journal of Medicine under the title Supported and Unsupported Claims in Medicinal Drug Advertisements, revealed that out of 394 claims in medicinal ads that appeared in 15 Indian medical journals in 2009, none were found to satisfy all of the World Health Organisation’s requirements. It was found also that terms like “tested”, “trusted”, “guaranteed success” and “matchless safety” were used without substantiating evidence (Sinha 2011b).

SOURCE: TOI

In a raid on the  premises of a drug manufacturing unit operating from Bagvania village near Baddi, sleuths  from Delhi Zone of the Directorate of Revenue Intelligence, along with police officials,  unearthed a massive hoard of veterinary and allopathic medicine, which the drug manufacturing unit, Ten Star, had not been licensed to manufacture. According to Drug Controller Navneet Marwaha, who received a tip off from a Joint Director in the Directorate of Revenue Intelligence and participated in the bust, the pharmaceutical formulations seized in the raid were found to be fraudulently labeled with the names of companies like Torranto Welcare Pharmaceuticals, Tranesia Bioceuticals, MPPL Rudrapur and Excel Biolife Private Limited. On completion of investigations, a case will be registered against Ten Star under Sections 18(a)(i) of the Drugs and Cosmetics Act, Mr. Marwah said.

SOURCE: The TRIBUNE

Government of India sources reveal shocking statistics on the incidence of spurious and sub-standard drugs in India. On a positive note, there are indications of fresh initiatives by means of which the government is gearing up to meet the challenge.

Sub-standard and irrational drugs in the Indian market are a matter of serious concern, according to government sources. One such source - the Union Ministry of Health, estimates that out of the one lakh crores worth of drugs produced in India, as many as 5000 crores worth are sub-standard. In a study commissioned by another government body – the Planning Commission, it was found that of the top 25 products sold in the country in 1999, ten - comprising blood tonics, cough expectorants, non-drug formulations, analgesics, nutrients and a liver drug - were hazardous, non-essential, or irrational. Practically all the major drug manufacturers were bringing out irrational formulations, the study also reports (Sinha 2011a). In another damning indictment, the DCGI – the Drug Controller General of India, estimates that  46 FDCs (Fixed Drug Combinations) continue to be available in the market despite being banned, while another 1,067 of them are marketed with the approval of state drug controllers, but without the DCGI’s consent (Sinha 2011a)
Two important factor are responsible for the proliferation of spurious and sub standard drugs in the country, according to the Planning Commission study cited above. The first relates to the regulatory instrument – the Drug and Cosmetics Act, which is either not effectively enforced, or is subject to multiple interpretations, making it ineffectual. In an effort to strengthen the regulatory mechanism, guidelines are now being formulated to specify the time frame within which pharmaceutical formulations will have to be taken off the shelves, once they are identified as sub standard. At this time, it is not even clear as to which officials are responsible for taking action (Sinha 2011a).

SOURCE: TOI