Drug controller cracks whip on e-pharmacies selling drugs without licences

Last December the Delhi High Court had said online sale of medicines without a licence was injuncted, and had instructed the government to ensure that the same was prohibited forthwith

The Drug Controller General of India (DCGI) has sent a directive to the state drug regulators to take “necessary action” in accordance with the Delhi High Court’s order of December 2018 that barred online sales of medicines without a licence.

At present, no licence is issued for online pharmacies as such as there are no comprehensive rules to regulate the sector. E-pharmacies follow the marketplace model whereby they operate through a licensed medicine retailer partner to service a prescription or order that they have generated through their online platform. Sources in the government said if the current model was allowed to continue, then what was the need to have rules to regulate the space.

“The draft rules to regulate online pharmacies were released last year, but are yet to be notified. Until they are notified, the e-pharmacy model cannot be allowed to operate,” said a senior government official. A group of ministers (GoM) had recently met to discuss regulations for e-pharmacies.

The industry feels otherwise. Senior executives of leading e-pharmacies in the country said they would wait until the Central Drugs Standard Control Organization (CDSCO) issued a formal notification saying that the current model of servicing customers through generating prescriptions online would not be allowed….click here

Shilpa Medicare surges 13% after receiving EIR from USFDA

The stock surged 13% to Rs 434 on the BSE in morning trade after the company said it has received EIR from the US health regulator for it’s both facilities located at Raichur, Karnataka.

 

Shares of Shilpa Medicare have surged by 13% to Rs 434 per share on the BSE in morning trade after the company said that it has received Establishment Inspection Report (EIR) from the US health regulator for both of its facilities located at Raichur, Karnataka.
“Our both active pharmaceutical ingredient (API) manufacturing facilities located at Raichur, Karnataka, received EIR from the US Food and Drug Administration (US FDA),” Shilpa Medicare said in a regulatory filing.

This inspection was carried out between 16th and 19th January, 2018. The inspection has now been closed by USFDA, it added.

On January this year, Shilpa Medicare had announced that the USFDA has completed inspection of Company’s API facilities Unit-I and Unit-II located at Raichur, Karnataka, India with three 483 observations. The Company said it is in the process of submission of corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of inspection.

In calendar year 2018, Shilpa Medicare had underperformed the market by falling 38% as compared to 6.4% rise in the S&P BSE Sensex till Tuesday. The stock hit 52-week low of Rs 374 on June 5, 2018 in intra-day trade.(CLICK HERE : SHILPA MEDICARE SHARE PRICE)

At 10:05 am; the stock was trading 10% higher at Rs 424 against 0.09% gain in the benchmark index. The counter has seen multiple fold jump in trading volumes with a combined 492,116 shares changed hands on the BSE and NSE so far.

News Source : BS