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The revised timetable for implementation of India's traceability scheme for exported medicines

includes two other key dates in the coming months, namely a deadline of 1 January 2012 for adding serialised codes to secondary packaging (2D or 1D code) and 1 July 2012 for primary packaging (2D datamatrix).
India has implemented its mandatory barcoding scheme for tertiary packaging of exported pharmaceutical shipments, in accordance with plans first unveiled in June 2011.

A circular issued by the Directorate General of Foreign Trade on October 25 confirms that exporters of medicines will have to add a 1D barcode to shipper or cartons of pharmaceuticals manufactured on or after October 1, 2011, encoding a unique product identification code (GTIN), batch number, expiry date and a unique serial number for the tertiary pack.

The 1D barcode is in addition to any existing statutory marking and labelling requirements, and data encoded in the barcodes must also be printed in human-readable form.

Worrisome Statistics :

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.

Busted in Baddi :

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.

Deceptive Medicinal Drug Ads to be scrutinized :

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.

Vigilance Stepped up to prevent Fake Drugs

The district administration of Gautam Budh Nagar has stepped up vigilance to prevent fake drugs infiltrating the markets following reports that manufacture of illicit medicines is thriving in western Uttar Pradesh. In a drive to check production of fake drugs, the district administration has cancelled licences of three non-functional drug-manufacturing units and sealed two chemist outlets operating without a licence, apart from checking 35 drug factories and nine private blood banks in Noida.

Drug alert system launched by Gujarat FDCA :

In another move to remove dubious medical formulations from the market place, the Gujarat FDCA (Food and Drug Control Administration), in a first of its kind initiative in the country, has instituted an e-governance system by which Not of Standard Quality (NSQ) drugs are speedily recalled and procedural delays circumvented. Food & Drugs Control Administration (FDCA) Commissioner Dr H G Koshia explains how the system works.

PharmaSecure is implementing Bar coding in major Pharmaceutical plants across India :

Over 28 pharmaceutical manufacturing facilities in India are in the process of complying with the bar coding requirement for exports which came into effect from Oct 1, 2011 in partnership with PharmaSecure, Inc.

US Drug Racketeers Convicted :

Arturo Godinez, who formerly ran two assisted living facilities in Florida, and his accomplice, Joel de la Osa, both of Miami, USA, have been convicted of selling counterfeit, stolen and mis-labeled medicines through a wholesale pharmaceutical business whose illegal trading in pharmaceutical products is believed to have garnered profits worth $ 20 million.

Chinese Get Tough :

A number of steps taken by the Chinese government suggest that it is demonstrating political will to contain the counterfeit medicines racket in the country (Taylor 2011). One of these relates to what has come to be known as the third shift (also known as the midnight shift or the ghost shift) - terms that refer to the phenomenon of the licensed manufacturer of a product clandestinely manufacturing some of it for sale on the sly.

Nigeria Battles Drug Counterfeiters :

Dr. Paul B. Orhii, Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), in an interview with Ruth Choji of Leadership Weekend, said that NASDAC had been able to eliminate about 5% of the imported fake drugs from the market in the country’s big cities. He contended that NASDAC had put up a good fight, especially considering that with crackdown on narcotics, drugs barons had begun to make their presence felt in the less risky and more profitable business of counterfeit medicine. He underscored the inadequacy of infrastructural and funding constraints in NAFDAC’s policing activities.